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JNJ-61393215

Phase 2

Major Depressive Disorder With Anxious Distress | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Apr 29, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment222

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-61393215 · 6 trials · 2 indications

Phase 2 1Phase 1 5
NCT04080752A Study of JNJ-61393215 in the Treatment of DepressionMajor Depressive Disorder With Anxious Distress
COMPLETED222 Analytics
PHASE2COMPLETED
A Study of JNJ-61393215 in the Treatment of Depression
Major Depressive Disorder With Anxious DistressUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
Baseline and Week 6

Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 42 days

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Plasma Concentration of JNJ-61393215
Predose, up to 96 hours postdose (up to Day 5)

Plasma samples will be analyzed to determine concentrations of JNJ-61393215 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).

Part 1: Maximum Observed Analyte Concentration (Cmax) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Cmax is defined as the maximum observed analyte concentration.

Part 1: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

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

Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to the Time of Last Measurable Concentration (AUC[0-last]) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

AUC(0-last) is defined as the area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification level \[non-BQL\]) analyte concentration calculated by linear-linear trapezoidal summation.

Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

AUC (0-infinity) is defined as the area under the analyte concentration vs. time curve from time 0 to infinite time, calculated as AUC(0-last) + Clast/lambda(z), where Clast is the last observed measurable (non-BQL) analyte concentration.

Part 1: Apparent Terminal Elimination Rate Constant (lambda[z]) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

lambda(z) is estimated by linear regression using the terminal logarithmic (log)-linear phase of the log transformed concentration vs time data.

Part 1: Apparent Elimination Half-Life (t1/2) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

T1/2 is defined as the apparent terminal elimination half-life and is calculated as 0.693/lambda(z).

Part 1: Apparent Oral Clearance (CL/F) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Part 1: Apparent Volume of Distribution (Vdz/F) of JNJ-61393215 Suspension
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired analyte concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed.

Part 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of JNJ 61393215 Suspension
Up to 7 Weeks

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.

Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-61393215 Capsule
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Cmax is defined as the maximum observed analyte concentration.

Part 2: Area Under the Analyte Concentration-time Curve from Time Zero to the Time of Last Measurable Concentration (AUC[0-last]) of JNJ-61393215 Capsule
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

AUC(0-last) is defined as the area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification level \[non-BQL\]) analyte concentration calculated by linear-linear trapezoidal summation.

Part 2: Area Under the Analyte Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-61393215 Capsule
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

AUC(0-infinity) is defined as the area under the analyte concentration vs. time curve from time 0 to infinite time, calculated as AUC(0-last) + Clast/lambda(z), where Clast is the last observed measurable (non-BQL) analyte concentration.

Part 3: Maximum Observed Analyte Concentration (Cmax) of JNJ-61393215 Suspension
Predose, 20, 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6 and 12 hours postdose on Day 1 and Day 7; 24 and 48 hours postdose on Day 7

Cmax is defined as the maximum observed analyte concentration.

Part 3: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours postdose on Day 1 and Day 7, 24 and 48 hours postdose on Day 7

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

Part 3: Area Under the Analyte Concentration-time Curve from Time 0 to 24 Hours (AUC [0-24]) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours postdose on Day 1 and Day 7, 24 hours postdose on Day 7

Area under the analyte concentration vs time curve from time 0 to 24 hours, calculated by linear-linear trapezoidal summation.

Part 3: Maximum Trough Concentration (Ctrough) of JNJ-61393215 Suspension
Predose on day 1, 2, 3, 4, 5, 6, 7 and 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24 and 48 hours postdose on Day 7

Ctrough is defined as the observed analyte concentration just prior to the beginning or at the end of a dosing interval. Ctrough estimation does not include the concentration that occurs just prior to the first dose.

Part 3: Minimum Observed Analyte Concentration (Cmin) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24 and 48 hours postdose on Day 7

Cmin is defined as the minimum observed analyte concentration during the dosing interval.

Part 3: Average Analyte Concentration (Cavg) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24 and 48 hours postdose on Day 7

Cavg is defined as the value of the average analyte concentration at steady state over the dosing interval.

Part 3: Fluctuation Index (FI) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

FI is estimated as the percentage fluctuation (variation) between the maximum and minimum analyte concentration at steady state.

Part 3: Volume of Distribution at Steady-State (Vss) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-infinity\])\*(AUMC\[0-infinity\])/AUC\[0-infinity\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time.

Part 3: Apparent Oral Clearance (CL/F) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Part 3: Apparent Terminal Elimination Rate Constant (lambda[z]) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

lambda(z) is estimated by linear regression using the terminal logarithmic (log)-linear phase of the log transformed concentration vs time data.

Part 3: Apparent Elimination Half-Life (t1/2) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

T1/2 is defined as the apparent terminal elimination half-life and is calculated as 0.693/lambda(z).

Part 3: Peak by Trough Ratio of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose on Day 7

Peak by trough ratio is defined as the ratio of the maximum observed analyte concentration to the minimum observed analyte concentration.

Part 3: Observed Accumulation Index Based on AUC (AR AUC) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on Day 1 and 7

AR AUC is determined after multiple-dose administration and calculated as AUC (0-24h) on day 7 divided by AUC (0-24h) on day 1.

Part 3: Observed Accumulation Index Based on Cmax (ARCmax) of JNJ-61393215 Suspension
Predose, 20 and 40 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on Day 1 and 7

ARCmax is determined after multiple-dose administration and calculated as Cmax on day 7 divided by Cmax on day 1.

Maximum Plasma Concentration (Cmax) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

Cmax is the maximum observed plasma concentration.

Last Quantifiable Plasma Concentration (Clast) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

Clast is the last quantifiable Plasma concentration.

Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

Tmax is the time to reach maximum plasma concentration.

Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

Tlast is the time to last observed quantifiable plasma concentration.

Area Under Plasma-Concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

AUClast is the area under the plasma concentration-time curve from time zero to last quantifiable time.

Area Under Plasma-Concentration Curve from Time 0 to Infinite Time (AUCinfinity) of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

AUCinfinity 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.

First-Order Rate Constant Associated with the Terminal Portion of the Curve [Lambda(z)] of JNJ-61393215
Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)

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.

Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
up to 4 weeks
Time To Reach The Maximum Plasma Concentration (Tmax)
Day 1

Tmax is time to reach the maximum plasma concentration.

Maximum Plasma Concentration (Cmax)
Day 1

Cmax is maximum plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
Day 1

AUC\[0-24\] is area under the plasma concentration- time curve from time \[0 to 24\].

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)
Days 2 to 6

Ctrough is 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.

Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin)
Day 7

Cmin is minimum observed plasma concentration during dosing interval (tau).

Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Day 7

Cavg is average plasma concentration at steady state over the dosing interval.

Fluctuation Index (FI)
Day 7

Fluctuation Index is defined as percentage of fluctuation, calculated as: 100\*(\[Cmax-Cmin\]/Cavg).

Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F)
Day 7

CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state.

Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z])
Day 7

Lambda\[Z\] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term)
Day 7

T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only.

Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref)
Day 7

Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 \[steady-state\]/ref (day 1).

Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref)
Day 7

Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time \[0 to 24\] (AUC\[0-24\]) test (day 7 \[steady-state\]/ref (day 1).

Number of Participants With Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability
Up to follow-up phase (7 to 14 days after study drug administration)
Maximum Plasma Concentration (Cmax) of JNJ-61393125
Up to Day 4

The Cmax is the maximum observed plasma concentration.

Last Quantifiable Plasma Concentration (Clast) of JNJ-61393125
Up to Day 4

The Clast is the last quantifiable plasma concentration.

Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393125
Up to Day 4

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

Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393125
Up to Day 4

The Tlast is defined as the time of the last quantifiable plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration of JNJ-61393125
Up to Day 4

The (AUC \[0-last\]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-61393125
Up to Day 4

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(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

First Order Rate Constant (Lambda[z]) of JNJ-61393125
Up to Day 4

Lambda(z) is first-order 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-61393125
Up to Day 4

Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

Total Clearance (CL/F) of JNJ-61393125
Up to Day 4

Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: D/AUC infinity.

Creatinine Clearance (CLcr) of JNJ-61393125
Up to Day 4

Secondary Endpoints

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6
Baseline and Week 6
Change From Baseline in HAM-A Total Score at Weeks 2 and 4
Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Baseline and Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-61393215 135 milligram (mg)EXPERIMENTALParticipants will receive JNJ-61393215 135 mg (3\*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
JNJ-61393215EXPERIMENTALParticipants will receive one of 3 single oral doses of JNJ-61393215 on Day 1, escalated sequentially based on the safety review in Cohorts 1, 2, and 3 up to Day 5.
Part 1 (Single Ascending Dose [SAD]): Cohort 1EXPERIMENTALParticipants will receive single oral dose of JNJ-61393215 145 milligram (mg) suspension or matching placebo on day 1, under fasted conditions.
Part 1 SAD: Cohort 2EXPERIMENTALParticipants will receive single oral dose of JNJ-61393215 225 mg suspension or matching placebo on day 1 under fasted conditions. Dose in this cohort will be determined based on safety and PK data of cohort 1.
Part 2 Cohort 3: Treatment Sequence CDEFEXPERIMENTALParticipants will receive single oral dose of JNJ-61393215 30 mg suspension under fasted condition (Treatment C) in Period 1, then participants will receive single oral dose of JNJ-61393215 30 mg capsule under fasted condition (Treatment D) in Period 2, single oral dose of JNJ-61393215 30 mg capsule with high fat/high-calorie breakfast (Treatment E) in Period 3 followed by single oral dose of JNJ-61393215 30 mg capsule with standardized breakfast (Treatment F) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods.
Part 2 Cohort 3: Treatment Sequence DFCEEXPERIMENTALParticipants will receive Treatment D in Period 1, then Treatment F in Period 2, then Treatment C in Period 3 followed by Treatment E in Period 4 on Day 1.
Part 2 Cohort 3: Treatment Sequence ECFDEXPERIMENTALParticipants will receive Treatment E in Period 1, then Treatment C in Period 2, then Treatment F in Period 3 followed by Treatment D in Period 4 on Day 1.
Part 2 Cohort 3: Treatment Sequence FEDCEXPERIMENTALParticipants will receive Treatment F in Period 1, then Treatment E in Period 2, then Treatment D in Period 3 followed by Treatment C in Period 4 on Day 1.
Part 2 Cohort 4: Treatment Sequence GHIJEXPERIMENTALParticipants will receive single oral dose of JNJ-61393215 suspension under fasted condition (Treatment G) in Period 1, then participants will receive single oral dose of JNJ-61393215 capsule under fasted condition (Treatment H) in Period 2, single oral dose of JNJ-61393215 capsule with high fat/high-calorie breakfast (Treatment I) in Period 3 followed by single oral dose of JNJ-61393215 capsule with standardized breakfast (Treatment J) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. Dose in this cohort will be based on the results obtained in Part 1.
Part 2 Cohort 4: Treatment Sequence HJGIEXPERIMENTALParticipants will receive Treatment H in Period 1, then Treatment J in Period 2, then Treatment D in Period G followed by Treatment I in Period 4 on Day 1.
Part 2 Cohort 4: Treatment Sequence IGJHEXPERIMENTALParticipants will receive Treatment I in Period 1, then Treatment G in Period 2, then Treatment J in Period 3 followed by Treatment H in Period 4 on Day 1.
Part 2 Cohort 4: Treatment Sequence JIHGEXPERIMENTALParticipants will receive Treatment J in Period 1, then Treatment I in Period 2, then Treatment H in Period 3 followed by Treatment G in Period 4 on Day 1.
Part 3 Cohort 5: Multiple Ascending DoseEXPERIMENTALParticipants will receive oral JNJ-61393215 145 mg suspension or matching placebo once daily for 7 days under fasted conditions.
Part 3 Cohort 6: Multiple Ascending DoseEXPERIMENTALParticipants will receive oral JNJ-61393215 225 mg suspension or matching placebo once daily for 7 days under fasted conditions. Dose may be lowered or increased based on the evaluation of safety and PK of Cohort 5. This dose may be the same as the dose chosen for Cohort 2 (Part 1), or it could be different.
JNJ-61393215 2 mg + Ritonavir 100 mgEXPERIMENTALParticipants will receive suspension of JNJ-61393215 2 mg (Day 1 and 5) orally and tablet of Ritonavir 100 mg twice a Day (Day 4-14) orally.
JNJ-61393215 (Multiple Ascending Dose Phase)EXPERIMENTALParticipants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort.
Placebo (Multiple Ascending Dose Phase)PLACEBO_COMPARATORParticipants will receive JNJ- 61393215 matching placebo for 7 days.
Part 1: Cohort 1EXPERIMENTALParticipants will receive 1 milligram (mg) JNJ-61393215 or placebo.
Part 1: Cohort 2EXPERIMENTALParticipants will receive 5 mg JNJ-61393215 or placebo.
Part 1: Cohort 3EXPERIMENTALParticipants will receive 15 mg JNJ-61393215 or placebo.
Part 1: Cohort 4EXPERIMENTALParticipants will receive 30 mg JNJ-61393215 or placebo.
Part 1: Cohort 5EXPERIMENTALParticipants will receive 45 mg JNJ-61393215 or placebo.
Part 1: Cohort 6EXPERIMENTALParticipants will receive 60 mg JNJ-61393215 or placebo.
Part 1: Cohort 7EXPERIMENTALParticipants will receive 90 mg JNJ-61393215 or placebo.
Part 1: Cohort 8EXPERIMENTALParticipants will receive 120 mg JNJ-61393215 or placebo.
Part 2EXPERIMENTALParticipants will receive JNJ-61393215 (dose to be determined).
Part 3EXPERIMENTALParticipants will receive JNJ-61393125 (dose to be determined) or placebo under fed conditions.

Interventions

NameTypeDescription
JNJ-61393215DRUGJNJ-61393215 will be administrated orally.
PlaceboDRUGMatching placebo will be administered orally.
RitonavirDRUGParticipants will receive 100 mg of ritonavir tablet orally.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m\^2) * Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress...

Countries:United StatesMoldovaRussiaUkraineUnited KingdomJapanNetherlands
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Frequently asked questions about JNJ-61393215

What is JNJ-61393215 used for?

JNJ-61393215 is an investigational small molecule being studied for use in healthy participants and in Major Depressive Disorder with Anxious Distress. It is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes JNJ-61393215?

JNJ-61393215 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company has completed five Phase 1 clinical trials for this investigational drug.

What phase is JNJ-61393215 in?

JNJ-61393215 is in Phase 1 clinical development. All five of its clinical trials have been completed, with a total enrollment of 244 participants. It remains an investigational drug and has not received FDA approval.

What clinical trials is JNJ-61393215 in?

JNJ-61393215 has completed five Phase 1 trials, including NCT02812251, NCT03007693, NCT03593954, and NCT03649997. These trials studied safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants, with one trial assessing the effect of ritonavir on the drug.

Is JNJ-61393215 the same as JNJ 61393215?

Yes, JNJ-61393215 is the same drug as JNJ 61393215. The name appears in clinical trial records with and without a hyphen, but both refer to the same investigational small molecule being developed by Johnson & Johnson.