A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants

NCT ID: NCT03931447

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2020-02-10

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-72537634

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

Participants will receive matching placebo as oral capsule in all cohorts.

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.

Group Type: EXPERIMENTAL

JNJ-72537634

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

Participants will receive matching placebo as oral capsule in all cohorts.

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.

Group Type: EXPERIMENTAL

JNJ-72537634

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

Participants will receive matching placebo as oral capsule in all cohorts.

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.

Group Type: EXPERIMENTAL

JNJ-72537634

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

Participants will receive matching placebo as oral capsule in all cohorts.

Interventions

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.

Intervention Type: BIOLOGICAL

Placebo

Participants will receive matching placebo as oral capsule in all cohorts.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of at least 50 kilogram (kg)
• Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
• Be healthy on the basis of clinical laboratory tests performed at screening. 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
• Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission
• 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

Exclusion Criteria

• 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
• If female, has a positive serum pregnancy test at screening, a positive urine pregnancy test at admission, or is lactating prior to study enrollment
• 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: barbiturates, benzodiazepines, tetrahydrocannabinol (THC), cocaine, opiates, methamphetamines, tricyclic antidepressants (TCA), methadone, 3,4-methylenedioxymethamphetamine (MDMA), oxycodone, and amphetamines

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

72537634IBD1001

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003700-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108615

Identifier Type: -

Identifier Source: org_study_id