| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Biological: JNJ-72537634 Biological: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Other |
| Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study To Assess The Safety And Tolerability Of JNJ-72537634 In Healthy Participants |
| Actual Study Start Date : | April 30, 2019 |
| Actual Primary Completion Date : | February 10, 2020 |
| Actual Study Completion Date : | February 10, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD)
Each participant will receive pretreatment with oral antibiotic; followed by a single day (SD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1.
|
Biological: JNJ-72537634
Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.
Biological: Placebo Participants will receive matching placebo as oral capsule in all cohorts.
|
|
Experimental: Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD)
Each participant will receive pretreatment with oral antibiotic; followed by a SD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1.
|
Biological: JNJ-72537634
Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.
Biological: Placebo Participants will receive matching placebo as oral capsule in all cohorts.
|
|
Experimental: Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD)
Each participant will receive pretreatment with oral antibiotic; followed by a multiple day (MD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1 for 14 consecutive days.
|
Biological: JNJ-72537634
Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.
Biological: Placebo Participants will receive matching placebo as oral capsule in all cohorts.
|
|
Experimental: Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)
Each participant will receive pretreatment with oral antibiotic; followed by a MD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1 for 14 consecutive days.
|
Biological: JNJ-72537634
Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.
Biological: Placebo Participants will receive matching placebo as oral capsule in all cohorts.
|
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Belgium | |
| Clinical Pharmacology Unit | |
| Merksem, Belgium, 2170 | |
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 26, 2019 | ||||||
| First Posted Date ICMJE | April 30, 2019 | ||||||
| Last Update Posted Date | March 18, 2021 | ||||||
| Actual Study Start Date ICMJE | April 30, 2019 | ||||||
| Actual Primary Completion Date | February 10, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants | ||||||
| Official Title ICMJE | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study To Assess The Safety And Tolerability Of JNJ-72537634 In Healthy Participants | ||||||
| Brief Summary | The purpose of the study is to assess the safety and tolerability of JNJ-72537634 compared with placebo in healthy participants after administration of single and multiple day doses. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other |
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| Condition ICMJE | Healthy | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
33 | ||||||
| Original Estimated Enrollment ICMJE |
46 | ||||||
| Actual Study Completion Date ICMJE | February 10, 2020 | ||||||
| Actual Primary Completion Date | February 10, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Belgium | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03931447 | ||||||
| Other Study ID Numbers ICMJE | CR108615 72537634IBD1001 ( Other Identifier: Janssen Research & Development, LLC ) 2018-003700-39 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Janssen Research & Development, LLC | ||||||
| Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Janssen Research & Development, LLC | ||||||
| Verification Date | March 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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