Clinical trial NCT03723746: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 Months post final dose or up to Day 84
measure: 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
timeFrame: 3 Months post final dose or up to Day 98
measure: 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
timeFrame: Predose up to Day 84
measure: 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
timeFrame: Predose up to Day 98
Secondary outcomes:
measure: Detection and Abundance of JNJ-67670187
timeFrame: Pre-dose, up to Day 82 (SD) and up to Day 98 (MD)
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: