A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
NCT ID: NCT03346122
Last Updated: 2019-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2017-11-15
2018-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)
Participants 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.
JNJ-64991524 Dose Level 1
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)
Participants 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.
JNJ-64991524 Dose Level 2
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)
Participants 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.
JNJ-64991524 Dose Level 3
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)
Participants 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.
JNJ-64991524 Dose Level 4
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)
Participants 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.
JNJ-64991524 Dose Level 5
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1)
Participants 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.
JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2)
Participants 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.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
JNJ-64991524 Dose Level 7
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2)
Participants 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.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
JNJ-64991524 Dose Level 8
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2)
Participants 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.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
JNJ-64991524 Dose Level 9
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2)
Participants 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.
JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Interventions
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JNJ-64991524 Dose Level 1
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
JNJ-64991524 Dose Level 2
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
JNJ-64991524 Dose Level 3
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
JNJ-64991524 Dose Level 4
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
JNJ-64991524 Dose Level 5
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
JNJ-64991524 Dose Level 7
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 8
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 9
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, , Belgium
Countries
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Other Identifiers
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2017-000229-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64991524EDI1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108376
Identifier Type: -
Identifier Source: org_study_id
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