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History of Changes for Study: NCT03723746
A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Latest version (submitted February 18, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 26, 2018 None (earliest Version on record)
2 November 6, 2018 Recruitment Status, Study Status and Contacts/Locations
3 February 7, 2019 Study Status, Arms and Interventions, Contacts/Locations and Study Design
4 September 5, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 January 13, 2020 Recruitment Status and Study Status
6 February 18, 2020 Study Status
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Study NCT03723746
Submitted Date:  October 26, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR108532
Brief Title: A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study to Assess the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Secondary IDs: 2018-002287-81 [EudraCT Number]
67670187IBD1001 [Janssen Research & Development, LLC]
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: October 29, 2018
Primary Completion: May 25, 2020 [Anticipated]
Study Completion: May 25, 2020 [Anticipated]
First Submitted: October 26, 2018
First Submitted that
Met QC Criteria:
October 26, 2018
First Posted: October 30, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 26, 2018
Last Update Posted: October 30, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.
Detailed Description: 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.
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 9
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 144 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1: Dose 1 or Placebo (Part 1 - SD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 2: Dose 2 or Placebo (Part 1 - SD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 3: Dose 1 or Placebo (Part 2 - MD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 5: Dose 2 or Placebo (Part 2 - MD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD)
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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 7: Laxative + Dose 2 or Placebo (Part 3 - MD)
Participants will 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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 8: Antibiotic+Laxative+Dose 2 or Placebo (Part 3 - MD)
Participants will 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.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Experimental: Cohort 9: Dose 2 or Placebo (Part 3 - MD) + Biopsy (Optional)
Participants will 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. This cohort will only be performed if necessary based on detection of JNJ-67670187 after analysis of cohorts 1 to 8.
Biological: JNJ-67670187
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.
Biological: Placebo
Participants will receive matching placebo in all cohorts.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
[ Time Frame: 3 Months post final dose or up to Day 84 ]

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.
2. 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
[ Time Frame: 3 Months post final dose or up to Day 98 ]

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. 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
[ Time Frame: Predose up to Day 84 ]

Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
4. 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
[ Time Frame: Predose up to Day 98 ]

Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
Secondary Outcome Measures:
1. Detection and Abundance of JNJ-67670187
[ Time Frame: Pre-dose, up to Day 82 (SD) and up to Day 98 (MD) ]

Stool assessment will be done to characterize the presence of JNJ-67670187.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive, and a body weight of at least 50 kilogram (kg)
  • Be otherwise healthy on the basis of physical examination, medical history, and vital signs, and 12 lead electrocardiogram (ECG) performed at screening and at admission
  • Be otherwise healthy on the basis of clinical laboratory tests performed at screening and at admission. If the results of the serum chemistry panel, hematology, 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
  • All women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on day of admission
  • Must have normal bowel movements

Exclusion Criteria:

  • Has a positive serum pregnancy test at screening, a positive urine pregnancy test, or is a female still lactating prior to study intervention administration
  • An active cigarette smoker or has quit cigarette smoking within the previous 6 months
  • Has a positive urine toxicology screen at screening or at admission for substances of abuse including but not limited to cocaine, cannabinoids, amphetamines, benzodiazepines, barbiturates, opiates, tricyclic antidepressants and methadone
  • History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • Has an active systemic or GI acute or chronic infection as determined by appropriate clinical screening and laboratory tests
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: Belgium
Clinical Pharmacology Unit
Merksem, Belgium, 2170
Netherlands
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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