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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002287-81 | EudraCT Number | ||
| 67670187IBD1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.
This study will be a Phase 1 randomized double-blind, placebo controlled multi dose study in up to 144 adult healthy volunteers. The safety, tolerability and impact on the microbiome following intake of oral dose of JNJ-67670187 for up to 14 days will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose 1 or Placebo (Part 1 - SD) | Experimental | Participants will receive a single oral dose (single day [SD] Dose 1) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1. |
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| Cohort 2: Dose 2 or Placebo (Part 1 - SD) | Experimental | Participants will receive a single oral dose (Dose 2) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1. |
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| Cohort 3: Dose 1 or Placebo (Part 2 - MD) | Experimental | Participants will receive an oral dose (Multiple Day [MD] Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days without antibiotic pretreatment after an overnight fast in Part 2. |
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| Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD) | Experimental | Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. |
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| Cohort 5: Dose 2 or Placebo (Part 2 - MD) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67670187 | Biological | Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Single Day (SD) Dose: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious 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. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state. A 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. | 3 Months post final dose or up to Day 84 |
| Part 2 Multiple Day (MD) Dose : Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious 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. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 98 that were absent before treatment or that worsened relative to pre-treatment state. A 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. | 3 Months post final dose or up to Day 98 |
| Part 1 SD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability | Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported. | Predose up to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Detection and Abundance of JNJ-67670187 | Stool assessment will be done to characterize the presence of JNJ-67670187. | Pre-dose, up to Day 82 (SD) and up to Day 98 (MD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium | |||
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini |
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Participants will receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily without antibiotic pretreatment for 14 days after an overnight fast in Part 2. |
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| Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD) | Experimental | Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. |
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| Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3) | Experimental | Participants may receive pretreatment with an oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 7 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
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| Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3) | Experimental | Participants may receive pretreatment with an oral antibiotic and oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 8 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
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| Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy | Experimental | Participants may receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. After final dosing collection of sigmoid biopsies will be performed. Cohort 9 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
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| Placebo | Biological | Participants will receive matching placebo in all cohorts. |
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| Part 2 MD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability | Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported. | Predose up to Day 98 |
| Groningen |
| 9728 NZ |
| Netherlands |