Recent Updates
Recently added Catalysts

JNJ-54175446

Phase 1

Depressive Disorder, Major | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-54175446 · 7 trials · 2 indications

Phase 1 7
NCT03088644A Study to Investigate P2X7 Receptor Occupancy by JNJ-54175446 With the Newly Developed P2X7 Receptor Positron Emission Tomography (PET) Tracer 18F-JNJ-64413739Healthy
COMPLETED16 Analytics
NCT03058419A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy SubjectsHealthy
COMPLETED16 Analytics
NCT02902601A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive DisorderDepressive Disorder, Major
COMPLETED70 Analytics
NCT02930694A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female ParticipantsHealthy
COMPLETED32 Analytics
NCT02933762A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and PlasmaHealthy
COMPLETED25 Analytics
NCT02515955A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male ParticipantsHealthy
COMPLETED76 Analytics
NCT02475148A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy ParticipantsHealthy
COMPLETED76 Analytics
PHASE1COMPLETED
A Study to Investigate P2X7 Receptor Occupancy by JNJ-54175446 With the Newly Developed P2X7 Receptor Positron Emission Tomography (PET) Tracer 18F-JNJ-64413739
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Effective Radiation Dose Following Injection of 18F-JNJ-64413739
Up to 4 Weeks

The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of 18F-JNJ-64413739 and corrected for attenuation by computed tomography (CT) transmission scans using PET/CT. These measurements will be used to estimate effective radiation dose per organ and total body.

Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of 18F-JNJ-64413739
Up to 4 Weeks

The Distribution of 18F-JNJ-64413739 in brain will be measured by dynamic PET/magnetic resonance (MR) scans obtained from the time of injection for up to 120 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V\[t\]) of 18F-JNJ-64413739.

Part C: Test Retest Variability in the Distribution of 18F-JNJ-64413739
Up to 5 Weeks

Test Retest Variability within subjects will be assessed based on percent difference in V\[t\] following 18F-JNJ-64413739 PET/MR scans obtained at least 1 Week apart. V\[t\] will be the parameter for the estimated volume of distribution of the tracer derived from the kinetic model that best fits the data from Part B. It will be calculated by formula \[100\*abs (V\[t\]test - V\[t\]retest)/\[( V\[t\]test+ V\[t\]retest)/2\].

Part D: Plasma Concentrations of JNJ-54175446
Up to 5 Weeks

Descriptive statistics will be calculated for the plasma concentrations of JNJ-54175446.

Part D: Percentage of P2X7 Receptor Occupancy
Up to 5 Weeks

Percent reduction in V\[t\] of 18F-JNJ-64413739 in brain regions of interest will be calculated by PET/MR scans obtained at pre and post treatment with single doses of JNJ-54175446.

Maximum Observed Plasma Concentration (Cmax)
Up to Day 17

The Cmax is the maximum observed plasma concentration.

Plasma Trough Concentration (Ctrough)
Up to Day 17

Ctrough is defined as observed plasma concentration of drug just prior to the beginning or at the end of a dosing interval.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Up to Day 17

The Tmax is defined as actual sampling time to reach maximum observed concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last])
Up to Day 17

The AUClast is the area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit) concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Up to Day 17

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Elimination Rate Constant (Lambda [z])
Up to Day 17

Lambda (z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

Elimination Half-Life (t1/2)
Up to Day 17

The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Apparent Total Clearance (CL/F)
Up to Day 17

Apparent total clearance is calculated as dose/AUC(0-infinity).

Apparent Volume of Distribution (Vd/F)
Up to Day 17

Apparent volume of distribution, calculated as dose/(lambda\[z\]\*AUC\[0-infinity\]).

Parent to Metabolite Ratio (Cmax)
Up to Day 17

Parent to metabolite ratio Cmax is defined as the ratio of individual Cmax values between parent and metabolite.

Parent to Metabolite Ratio (AUC [Last])
Up to Day 17

Parent to metabolite ratio (AUC \[Last\]) is defined as ratio of individual (AUC \[Last\]) values between parent and metabolite.

Parent to Metabolite Ratio (AUC [infinity])
Up to Day 17

Parent to Metabolite Ratio (AUC \[infinity\]) is defined as the ratio of individual (AUC \[infinity\]) values between parent and metabolite.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to Day 17
Maximum Plasma Concentration (Cmax) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

The Cmax is the maximum observed plasma concentration.

Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

The Tmax is defined as actual sampling time to reach maximum plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Elimination Rate Constant (Lambda[z]) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

Elimination Half-Life (t1/2) of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Relative Bioavailability of JNJ-54175446
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of capsule to suspension formulation).

The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Part 1: Up to Day 2
Maximum Observed Plasma Concentration (Cmax) After Single- and Multiple-Dose Administration
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Minimum Observed Plasma Concentration (Cmin)During Dosing Interval
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Observed Plasma Concentration Just Prior to the Beginning or at the end of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Part 1: Day 1 - Day 2; Par 2: Day 1, Day 2 to 6, Day 7, Day 8
Time to Reach the Maximum Plasma Concentration, After Single- and Multiple-Dose Administration (Tmax)
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under The Concentration-Time Curve From 0 To t Hours Postdosing (AUCt)
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under the Concentration-Time Curve From 0 to 24 Hours Postdosing (AUC24h)
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration (Peak/Trough Ratio)
Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Number of Participants with Adverse Events
Baseline up to 14 or 21 days after study drug administration

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Minimum Observed Plasma Concentration (Cmin)
Baseline up to Day 17

The Cmin is the minimum observed plasma concentration.

Trough Plasma Concentration (Ctrough)
Baseline up to Day 17

The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.

Average Plasma Concentration at Steady State (Cavg,ss)
Baseline up to Day 17

The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau).

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Baseline up to Day 17

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Baseline up to Day 17

The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

Maximum Tolerated Dose of JNJ-54175446 in Part 1
Baseline up to 24 Hours after study drug administration
Maximum Observed Plasma and Cerebrospinal Fluid (CSF) Concentration (Cmax)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration

The Cmax is the maximum observed concentration.

Last Quantifiable Plasma and Cerebrospinal Fluid (CSF) Concentration (Clast)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
Time to Reach Maximum Observed Plasma and Cerebrospinal Fluid Concentration (Tmax)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
Time to Last Quantifiable Plasma and Cerebrospinal Fluid Concentration (Tlast)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
Area Under Curve From Time of Administration up to the Last Time Point with a Measurable Plasma and Cerebrospinal Fluid Concentration (AUClast)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
Area Under the Plasma and Cerebrospinal Fluid Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
First-order Rate Constant (Lambda[z])
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration
Total Clearance (CL/F)
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration

Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability

Creatinine Clearance
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, 96, 120, 144 hours after study drug administration

Creatinine clearance was calculated by Cockroft-Gault formula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter).

Secondary Endpoints

Part A, B and C: Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of 18F-JNJ-64413739
Part A and B: Up to 4 Weeks; Part C: Up to 5 Weeks
Part D: Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of JNJ-54175446
Up to 5 Weeks
Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to follow up (14 to 21 days after last dose)
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: 18F-JNJ-64413739EXPERIMENTALSubjects will receive an intravenous (IV) bolus injection of 18F-JNJ-64413739 at a dose between 150 and 185 megaBecquerel (MBq) on Day 1 of Part A to investigate the total body biodistribution and measure the radiation dosimetry.
Part B: 18F-JNJ-64413739EXPERIMENTALSubjects will receive an IV bolus injection of 18F-JNJ-64413739 at a dose between 150 and 185 MBq on Day 1 of Part B to measure the uptake, distribution, and clearance in brain.
Part C: 18F-JNJ-64413739EXPERIMENTALSubjects will receive an IV bolus injection of 18F-JNJ-64413739 for a PET/MR scan on Day 1 and a repeat 18F-JNJ-64413739 PET/magnetic resonance (MR) scan at least 1 week later to determine the test-retest variability in V\[t\]. 18F-JNJ-64413739 doses will be between 150 and 185 MBq.
Part D: JNJ-54175446 + 18F-JNJ-64413739EXPERIMENTALSubjects will have a baseline 18F-JNJ-64413739 PET/MR scan on Day 1. On Day 2 they will receive JNJ-54175446 (maximum 600 milligram \[mg\]) orally (after light breakfast) and then an IV injection of 18F-JNJ-64413739 four hours after dosing for a PET/MR scan. At least 1 week later, they will receive another dose of JNJ-54175446, and then an IV injection of 18F-JNJ-64413739 four hours later for a second post-treatment PET/MR scan. 18F-JNJ-64413739 doses will be between 150 and 185 MBq.
Drug Cocktail + JNJ-54175446EXPERIMENTALAll subjects will receive a single dose of drug cocktail (consisting of midazolam \[2 milligram (mg)\], warfarin \[10 mg\], caffeine \[50 mg\], dextromethorphan \[30 mg\], bupropion \[150 mg\] and omeprazole \[20 mg\]) on Day 1, 7 and 11; JNJ-54175446 150 mg on Day 7, 9, 10 and 11 and JNJ-54175446 600 mg on Day 8.
Group A: JNJ-54175446EXPERIMENTALParticipants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10.
Group B: Placebo + JNJ-54175446EXPERIMENTALParticipants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10.
Group C: PlaceboPLACEBO_COMPARATORParticipants will receive placebo from Day 1 until Day 10.
Group 1: Treatment Sequence ABEXPERIMENTALParticipants will receive Treatment A \[JNJ-54175446, 50 milligram (mg) capsule\] on Day 1 of period 1 followed by Treatment B \[JNJ-54175446, 50 mg suspension\] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
Group 1: Treatment Sequence BAEXPERIMENTALParticipants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
Group 2: Treatment Sequence CDEXPERIMENTALParticipants will receive Treatment C \[JNJ-54175446, 100 mg capsule\] on Day 1 of period 1 followed by Treatment D \[JNJ-54175446, 100 mg suspension\] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
Group 2: Treatment Sequence DCEXPERIMENTALParticipants will receive Treatment D on Day 1 of period 1 followed by Treatment C on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg])EXPERIMENTALHealthy elderly participants will receive single dose of 30mg JNJ-54175446.
Part 1: Cohort A1 (JNJ-54175446 100mg)EXPERIMENTALHealthy elderly participants will receive single dose of 100mg JNJ-54175446.
Part 1: Cohort A1 (JNJ-54175446 300mg)EXPERIMENTALHealthy elderly participants will receive single dose of 300mg JNJ-54175446.
Part 1: Cohort A1 (Placebo)EXPERIMENTALHealthy elderly participants will receive single dose of placebo.
Part 1: Cohort A2 (JNJ-54175446 D1 mg)EXPERIMENTALHealthy elderly participants will receive an additional dose D1 mg \[less than or equal to (\<=) 600 mg\] of JNJ-54175446, to be determined.
Part 1: Cohort A3 (JNJ-54175446 D2 mg)EXPERIMENTALHealthy young participants will receive a single dose D2 mg (\<= 600 mg) of JNJ-54175446, to be determined.
Part 1: Cohort A3 (Placebo)EXPERIMENTALHealthy young participants will receive a single dose of placebo.
Part 2: Cohort B1 (JNJ-54175446 D3 mg)EXPERIMENTALHealthy elderly participants will receive multiple dose levels D3 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.
Part 2: Cohort B1 (Placebo)EXPERIMENTALHealthy elderly participants will receive placebo determined based on the results from Cohort A1.
Part 2: Cohort B2 (JNJ-54175446 D4 mg)EXPERIMENTALHealthy elderly participants will receive multiple dose levels D4 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.
Part 2: Cohort B2 (Placebo)EXPERIMENTALHealthy elderly participants will receive placebo determined based on the results from Cohort A1
Part 2: Cohort B3 (JNJ-54175446 D5 mg)EXPERIMENTALHealthy elderly participants will receive multiple dose levels D5 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.
Part 2: Cohort B3 (Placebo)EXPERIMENTALHealthy elderly participants will receive placebo determined based on the results from Cohort A1
Cohort 1EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 2EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 3EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 4EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 5EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 6EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 7EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Cohort 8EXPERIMENTALParticipants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
Part 1: Cohort 1EXPERIMENTALParticipants will receive either JNJ-54175446 0.5 milligram (mg) or placebo on Day 1.
Part 1: Cohort 2EXPERIMENTALParticipants will receive either JNJ-54175446 2.5 mg or placebo on Day 1.
Part 1: Cohort 3EXPERIMENTALParticipants will receive either JNJ-54175446 10 mg or placebo on Day 1.
Part 1: Cohort 4EXPERIMENTALParticipants will receive either JNJ-54175446 30 mg or placebo on Day 1.
Part 1: Cohort 5EXPERIMENTALParticipants will receive either JNJ-54175446 100 mg or placebo on Day 1.
Part 1: Cohort 6EXPERIMENTALParticipants will receive either JNJ-54175446 200 mg or placebo on Day 1.
Part 2: Cohort 7EXPERIMENTALParticipants will receive JNJ-54175446 on Day 1. The dose of JNJ-54175446 will be determined in part 1 as suitable dose.
Part 3: Cohort 8EXPERIMENTALParticipants will receive JNJ-54175446 on Day 1 along with high fat/high calorie breakfast. The dose of JNJ-54175446 will be determined in part 1 as suitable dose.

Interventions

NameTypeDescription
JNJ-54175446DRUGJNJ-54175446 up to 600 mg suspension for oral dose administration.
18F-JNJ-64413739DRUG18F-JNJ-64413739 fluid for injection administered intravenously.
JNJ-54175446 150 mgDRUGSubjects will receive JNJ-54175446 150 mg capsules orally (1\*100 mg + 1\*50 mg) under fasted conditions on Day 7, 9, 10 and 11.
JNJ-54175446 600 mgDRUGSubjects will receive JNJ-54175446 600 mg (6\*100 mg capsules) orally on Day 8.
Midazolam 2 mgDRUGSubjects will receive midazolam 2 mg oral emulsion \[2 (milligram per milliliter (mg/mL)\] as a drug cocktail on Day 1, 7 and 11.
Warfarin 10 mgDRUGSubjects will receive warfarin 10 mg tablets (2\*5 mg) orally as a drug cocktail on Day 1, 7 and 11.
Caffeine 50 mgDRUGSubjects will receive caffeine 50 mg tablet (1\*50 mg) orally as a drug cocktail on Day 1, 7 and 11.
Dextromethorphan 30 mgDRUGSubjects will receive dextromethorphan 30 mg capsule (1\*30 mg) orally as a drug cocktail on Day 1, 7 and 11.
Bupropion 150 mgDRUGSubjects will receive Bupropion 150 mg tablet (1\*150 mg) orally as a drug cocktail on Day 1, 7 and 11.
Omeprazole 20 mgDRUGSubjects will receive omeprazole 20 mg capsule (1\*20 mg) orally as a drug cocktail on Day 1, 7 and 11.
JNJ-54175446, 600 mgDRUGParticipants will receive JNJ-54175446, 600 mg as an oral suspension.
JNJ-54175446, 150 mgDRUGParticipants will receive JNJ-54175446, 150 mg as an oral suspension.
PlaceboOTHERMatching placebo to JNJ-54175446
JNJ-54175446 (capsule)DRUGParticipants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)DRUGParticipants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
MinocyclineDRUGParticipants will receive minocycline 100 mg as capsule twice daily.
JNJ 54175446 Matching PlaceboDRUGParticipants will receive placebo matching with JNJ 54175446 once daily orally.
D AmphetamineDRUGParticipants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
D Amphetamine Matching PlaceboDRUGParticipants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
JNJ 54175446DRUG -
High fat/high Calorie BreakfastOTHER -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) inclusive (BMI = weight/height\^2) * Nonsmoker (not smoked for 3 months prior to screening) * Is willing to allow the investigators to place an arterial catheter in the radial artery, is assessed via p...

Countries:BelgiumGermanyNetherlandsUnited States
Unlock Eligibility Criteria

Frequently asked questions about JNJ-54175446

What is JNJ-54175446 used for?

JNJ-54175446 is an investigational small molecule being studied for Major Depressive Disorder and in healthy participants. It is in Phase 1 clinical development and is not yet approved. All six completed trials have focused on safety, tolerability, pharmacokinetics, and drug interactions in healthy volunteers.

Who makes JNJ-54175446?

JNJ-54175446 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored six Phase 1 clinical trials of the drug, all of which have been completed.

What phase is JNJ-54175446 in?

JNJ-54175446 is in Phase 1 clinical development. All six trials listed for this drug are Phase 1 studies and have been completed. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is JNJ-54175446 in?

JNJ-54175446 has completed six Phase 1 trials, including NCT02475148, NCT02930694, NCT02933762, and NCT03058419. These studies evaluated safety, tolerability, bioavailability, food effects, and drug interactions in healthy participants, with total enrollment of 241 subjects.

Is JNJ-54175446 the same as any other drug?

No alternative names for JNJ-54175446 have been reported. The drug is identified solely by its compound number JNJ-54175446 in all clinical trial records and development documentation.