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JNJ-54861911

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials8
Total Enrollment235
FDA Designations
No designations recorded
Clinical Trials (8)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02611518A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy ParticipantsPHASE1 COMPLETED 32Apr 5, 2016Jun 14, 2016Feb 3, 20251 Germany
NCT02355561A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly ParticipantsPHASE1 COMPLETED 12Jan 1, 2015Mar 1, 2015Mar 3, 20171 Belgium
NCT02211079A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 SubstratesPHASE1 COMPLETED 16Sep 1, 2014Nov 1, 2014Nov 24, 20151 Netherlands
NCT02197884A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male ParticipantsPHASE1 COMPLETED 13Jul 1, 2014Sep 1, 2014Oct 15, 20141 Belgium
NCT02180269A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male ParticipantsPHASE1 COMPLETED 24Jun 1, 2014Aug 1, 2014Sep 12, 20141 Japan
NCT02260700A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male ParticipantsPHASE1 COMPLETED 12Sep 1, 2013Nov 1, 2013Oct 9, 20141 Belgium
NCT01887535A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly ParticipantsPHASE1 COMPLETED 70May 1, 2013Dec 1, 2013Jan 14, 20141 Belgium
NCT01827982A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With PlaceboPHASE1 COMPLETED 56Mar 1, 2013Jul 1, 2013Nov 10, 20141 Belgium
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Up to Day 17

The Cmax is the maximum observed concentration.

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

The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

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.

Maximum Plasma Concentration (Cmax) of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The Cmax is the maximum observed plasma concentration of JNJ-54861911.

Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.

Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The AUC (0-t) calculated by trapezoidal summation \[time t is the time of the last quantifiable concentration (C\[last\])\].

Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The AUC (0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.

Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-54861911 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

Elimination Rate Constant (Lambda [z]) of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

Terminal Half-life (t[1/2]) of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

The t(1/2) is defined as 0.693/Lambda (z).

Relative Bioavailability (F[rel]) of JNJ-54861911
Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period

Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).

Time to Reach Maximum Concentration (Tmax)
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

The Tmax is time to reach the maximum observed plasma concentration.

Time to Last Quantifiable Plasma Concentration (Tlast)
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

The Tlast is time to last observed quantifiable plasma concentration (Clast).

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), where AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24])
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.

Elimination Half-Life (t1/2)
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, is calculated as 0.693 divided by lambda(z), where lambda(z) is first-order rate constant associated with the terminal portion of the curve. The t1/2 is the measure of time, for plasma concentration to decrease by one half.

Elimination Rate Constant (lambda[z])
Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)

Lambda(z) is first-order elimination rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

Maximum Observed Plasma Concentration (Cmax) of JNJ-54861911 and diaminothiazine (DIAT)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

The Cmax is the maximum observed plasma concentration.

Time to Reach Maximum Concentration (Tmax) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

The Tmax is time to reach the maximum observed plasma concentration.

Time to Last Quantifiable Plasma Concentration (Tlast) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

The Tlast is time to last observed quantifiable plasma concentration (Clast).

Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

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

Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUC [0-infinity]) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), where AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

Area under the plasma concentration-time curve from time zero to time 24 hours.

Elimination Half-Life (t1/2) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, is calculated as 0.693 divided by lambda(z), where lambda(z) is first-order rate constant associated with the terminal portion of the curve. The t1/2 is the measure of time, for plasma concentration to decrease by one half.

Elimination Rate Constant (lambda[z]) of JNJ-54861911 and DIAT
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9

Lambda(z) is first-order elimination rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Screening up to 14 days after last dose administration or early withdrawal

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose administration, that were absent before treatment or that worsened relative to pretreatment state.

Maximum Plasma Concentration (Cmax)
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

The Cmax is the maximum observed plasma concentration.

Apparent Clearance (CL/F)
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1

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.

Rate of Absorption of JNJ-54861911
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

Rate of absorption will be measured using the peak concentration of JNJ-54861911 (following administration of solid dosage form and suspension dosage form) under fasted conditions and fed conditions.

Extent of Absorption of JNJ-54861911
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

Extent of absorption will be measured under fasted conditions and fed conditions, using the area under plasma concentrations of JNJ-54861911 versus time from time 0 to the last sample point (AUC\[0-t\]) and from time 0 to infinity (AUC\[0-inf\]).

The number of volunteers who experience adverse events as a measure of safety and tolerability of JNJ-54861911 after multiple dose administration in the target dose range and above
Up to 72 hours
Maximum Tolerated Dose (MTD) of JNJ-54861911
Up to 96 hours

The maximal tolerated dose (MTD) after single dose administration of JNJ-54861911 or the safety and tolerability at the maximum feasible dose level, whichever is reached first

Secondary Endpoints
Number of Participants with Adverse Events
Up to follow-up (5-7 Days after last dose of study drug administration)
Number of Participants with Adverse Events (AEs) and Serious AEs
Screening up to follow-up (7 to 14 days after last dose administration)
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Baseline up to follow-up (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel 1EXPERIMENTALParticipant will be administered a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 and Day 14 and JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 17.
Panel 2EXPERIMENTALParticipant will be administered a single oral dose of metformin 500-mg on Day 1 and Day 14 and JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 16.
Sequence 1 (ABC)EXPERIMENTALParticipants will receive Treatment A (single dose of JNJ-54861911 25 milligram \[mg\] formulation 1 \[reference\] under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg formulation 2 \[test\] under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg formulation 2 under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Sequence 2 (ACB)EXPERIMENTALParticipants will receive Treatment A in Period 1; followed by Treatment C in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Sequence 3 (BAC)EXPERIMENTALParticipants will receive Treatment B in Period 1; followed by Treatment A in Period 2; followed by Treatment C in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Sequence 4 (BCA)EXPERIMENTALParticipants will receive Treatment B in Period 1; followed by Treatment C in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Sequence 5 (CAB)EXPERIMENTALParticipants will receive Treatment C in Period 1; followed by Treatment A in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Sequence 6 (CBA)EXPERIMENTALParticipants will receive Treatment C in Period 1; followed by Treatment B in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
JNJ-54861911 + Caffeine + Midazolam +TolbutamideEXPERIMENTALJNJ-54861911, 50 milligram (mg) (2\*25 mg tablets) orally once daily from Day 2 to Day 9 along with caffeine 100 mg (2\*50 mg tablets), midazolam 2 mg (1 milliliter \[mL\], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9.
Itraconazole + JNJ-54861911 (Part 1)EXPERIMENTALSingle dose of JNJ-54861911, 25 milligram (mg) tablet orally on Day 1 and Day 9 along with itraconazole 200 mg (2\*100 mg capsule) orally once daily from Day 5 to Day 12.
Clarithromycin + JNJ-54861911 (Part 2)EXPERIMENTALSingle dose of JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9 along with clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.
Cohort AEXPERIMENTALSingle oral dose of either JNJ-54861911, 25 milligram (mg) tablet or matched placebo tablet on Day 1.
Cohort BEXPERIMENTALSingle oral dose of either JNJ-54861911, 50 mg (2\*25 mg tablets) or matched placebo tablets on Day 1.
Cohort CEXPERIMENTALSingle oral dose of either JNJ-54861911, 100 mg (4\*25 mg tablets) or matched placebo tablets on Day 1.
Cohort 1: JNJ-54861911 3 mgEXPERIMENTALParticipants will be administered single doses of JNJ-54861911 on Days 1 to 14. Initially the doses will be once per day, but the frequency of daily dosing (eg, once-daily, twice-daily, three times daily) may change prior to or during study conduct depending on the pharmacokinetic data from the ongoing single-ascending dose study (54861911ALZ1001) or ongoing cohorts in this current study. Actual dose levels as well as the magnitude of dose escalation will depend on the results of the ongoing single-ascending dose study, the observed safety and tolerability profile as well as the observed exposures.
Cohort 2: JNJ-54861911 10 mgEXPERIMENTAL -
Cohort 3: JNJ-54861911 30 mgEXPERIMENTAL -
Cohort 4: JNJ-54861911 80 mgEXPERIMENTAL -
Cohort 5: JNJ-54861911 25 mgEXPERIMENTAL -
Cohorts 1-4: PlaceboPLACEBO_COMPARATORParticipants in Cohorts 1-4 will receive matching placebo.
Part 1 - Cohort 1: JNJ-54861911 1 mgEXPERIMENTALFollowing each dose level the observed safety and tolerability profile will be evaluated. The dose will be escalated only if the observed safety and tolerability profile is acceptable.
Part 1 - Cohort 2: JNJ-54861911 3 mgEXPERIMENTAL -
Part 1 - Cohort 3: JNJ-54861911 9 mgEXPERIMENTAL -
Part 2 - Cohort 4: JNJ-54861911 9 mgEXPERIMENTAL -
Part 2 - Cohort 5: JNJ-54861911 27 mgEXPERIMENTAL -
Part 2 - Cohort 6: JNJ-54861911 81 mgEXPERIMENTAL -
Part 2 - Cohort 7: JNJ-54861911 160 mgEXPERIMENTAL -
Part 3 - Cohort 8: JNJ-54861911 (dose to be determined [tbd])EXPERIMENTAL -
Parts 1 through 3 - PlaceboPLACEBO_COMPARATORParticipants in each cohort will receive matching placebo.
Interventions
NameTypeDescription
RosuvastatinDRUGRosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14.
JNJ-54861911DRUGJNJ-54861911 will be administered at a dose of 25 mg once daily from Day 8 to Day 17 (in panel 1), Day 8 to 16 (in panel 2).
MetforminDRUGMetformin will be administered as a single oral 500 mg on Day 1 and Day 14.
JNJ-54861911 (Treatment A)DRUGParticipants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
JNJ-54861911 (Treatment B)DRUGParticipants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
JNJ-54861911 (Treatment C)DRUGParticipants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
CaffeineDRUGSingle oral dose of caffeine 100 mg (2\*50 mg tablets), on Day 1, 2, and 9.
MidazolamDRUGSingle oral dose of midazolam 2 mg (1 mL, 2 mg/mL solution), on Day 1, 2, and 9.
TolbutamideDRUGSingle oral dose of Tolbutamide 500 mg tablet, on Day 1, 2, and 9.
JNJ-54861911, 25 mgDRUGJNJ-54861911, 25 mg tablet orally on Day 1 and Day 9.
Itraconazole 200 mgDRUGItraconazole 200 mg (2\*100 mg capsule) orally once daily from Day 5 to Day 12.
Clarithromycin 500 mgDRUGClarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.
JNJ-54861911 (25 mg)DRUGSingle oral dose of JNJ-54861911, 25 mg on Day 1.
JNJ-54861911 (50 mg)DRUGSingle oral dose of JNJ-54861911, 50 mg on Day 1.
JNJ-54861911 (100 mg)DRUGSingle oral dose of JNJ-54861911, 100 mg on Day 1.
PlaceboDRUGSingle oral dose of placebo matched to JNJ-54861911 on Day 1.
JNJ-54861911 3 mgDRUGJNJ-54861911 3 mg will be administered as an oral suspension formulation.
JNJ-54861911 10 mgDRUGJNJ-54861911 10 mg will be administered as an oral suspension formulation.
JNJ-54861911 30 mgDRUGJNJ-54861911 30 mg will be administered as an oral suspension formulation.
JNJ-54861911 80 mgDRUGJNJ-54861911 80 mg will be administered as an oral suspension formulation.
JNJ-54861911 25 mgDRUGJNJ-54861911 25 mg will be administered as a solid dose formulation.
JNJ-54861911 1mgDRUGJNJ-54861911 1 mg will be administered as a single oral dose after an overnight fast of at least 10 hours.
JNJ-54861911 9 mgDRUGJNJ-54861911 9 mg will be administered as a single oral dose.
JNJ-54861911 27 mgDRUGJNJ-54861911 27 mg will be administered as a single oral dose.
JNJ-54861911 81 mgDRUGJNJ-54861911 81 mg will be administered as a single oral dose.
JNJ-54861911 160 mgDRUGJNJ-54861911 160 mg will be administered as a single oral dose.
JNJ-54861911 tbdDRUGThe dose of JNJ-54861911 will be derived from the results obtained in Parts 1 and 2.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study * Willing to adhere to the prohibitions and restrictions specified in this protocol * All woman must have a negative ...

Countries:GermanyBelgiumNetherlandsJapan
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