A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
NCT ID: NCT03723746
Last Updated: 2020-02-19
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
74 participants
INTERVENTIONAL
2018-10-25
2019-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
DOUBLE
Study Groups
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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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3)
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3)
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
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.
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.
Placebo
Participants will receive matching placebo in all cohorts.
Interventions
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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.
Placebo
Participants will receive matching placebo in all cohorts.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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Clinical Pharmacology Unit
Merksem, , Belgium
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, , Netherlands
Countries
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Other Identifiers
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2018-002287-81
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
67670187IBD1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108532
Identifier Type: -
Identifier Source: org_study_id
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