A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
3 other identifiers
interventional
86
1 country
1
Brief Summary
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2017
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2018
CompletedJanuary 24, 2019
January 1, 2019
1 year
November 15, 2017
January 22, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
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.
Up to Day 20
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
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.
Up to Day 28
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Secondary Outcomes (1)
Plasma Concentration of JNJ-64991524
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Study Arms (10)
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
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Eligibility Criteria
You may qualify if:
- Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)\^2 to 30 kg/m\^2, inclusive, at screening
- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
- Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
- Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
- A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -2
You may not qualify if:
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has a history of or is infected with human immunodeficiency virus (HIV \[positive serology for HIV antibody\]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, 2060, Belgium
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2017
First Posted
November 17, 2017
Study Start
November 15, 2017
Primary Completion
November 20, 2018
Study Completion
November 20, 2018
Last Updated
January 24, 2019
Record last verified: 2019-01