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JNJ-64991524 Dose Level 1

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03405441A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male ParticipantsPHASE1 COMPLETED 42 — — Jan 2, 2018Sep 4, 2018Apr 27, 20251 Netherlands
NCT03346122A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy ParticipantsPHASE1 COMPLETED 86 — — Nov 15, 2017Nov 20, 2018Jan 24, 20191 Belgium
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Study Endpoints
Primary Endpoints
Part 1 (Day-Time Dosing): Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to Week 8

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Part 2 (Night-Time Dosing): Number of Participants with AEs as a Measure of Safety and Tolerability
Up to Week 9

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to Day 20

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. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.

Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Up to Day 28

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. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.

Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.

Secondary Endpoints
Slow Wave Activity Recorded by the Electroencephalogram (EEG)
Pre-dose, 1 hour (h), 2h, and 4h post dose on Day 1
Part 1: PD of JNJ-55375515 as Assessed by Heart Rate Variability (HRV)
Pre-dose (Day 1) up to 24 hours post dose
Part 1: Saccadic Reaction Time (RT) as Measured by Saccadic Eye Movements
Pre-dose, 1 h, 2h, and 4h post dose on Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 (Panel 1): JNJ-55375515 and placeboEXPERIMENTALParticipants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.
Part 1 (Panel 2): JNJ-55375515 and placeboEXPERIMENTALParticipants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.
Part 2: JNJ-55375515 and placeboEXPERIMENTALParticipants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3.
Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)EXPERIMENTALParticipants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)EXPERIMENTALParticipants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)EXPERIMENTALParticipants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)EXPERIMENTALParticipants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7.
Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)EXPERIMENTALParticipants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1)EXPERIMENTALParticipants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2)EXPERIMENTALParticipants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1.
Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2)EXPERIMENTALParticipants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2)EXPERIMENTALParticipants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2)EXPERIMENTALParticipants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1.
Interventions
NameTypeDescription
JNJ-55375515 Dose Level 1DRUGParticipants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.
JNJ-55375515 Dose Level 2DRUGParticipants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.
JNJ-55375515 Dose Level 3DRUGParticipants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.
JNJ-55375515 Dose Level 4DRUGParticipants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.
JNJ-55375515 Dose Level 5DRUGParticipants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.
JNJ-55375515 Dose Level 6DRUGParticipants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.
PlaceboDRUGAll participants will receive matching placebo orally in Part 1 and Part 2 of the study.
JNJ-55375515DRUGParticipants will receive JNJ-55375515 as per the assigned treatment in Part 2.
JNJ-64991524 Dose Level 1DRUGParticipants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
JNJ-64991524 Dose Level 2DRUGParticipants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
JNJ-64991524 Dose Level 3DRUGParticipants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
JNJ-64991524 Dose Level 4DRUGParticipants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
JNJ-64991524 Dose Level 5DRUGParticipants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
JNJ-64991524 Dose Level 6DRUGParticipants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
JNJ-64991524 Dose Level 7DRUGParticipants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 8DRUGParticipants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 9DRUGParticipants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
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Eligibility Criteria
Age Range18 Years — 54 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m\^2) inclusive (BMI=weight/height\^2) * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation or urinalysi...

Countries:NetherlandsBelgium
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