A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: JNJ-67670187; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03723746

CR108532

2018-002287-81 (EudraCT Number)

67670187IBD1001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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74 participants in 9 patient groups

Cohort 1: Dose 1 or Placebo (Part 1 - SD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 2: Dose 2 or Placebo (Part 1 - SD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 3: Dose 1 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 5: Dose 2 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3)

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187

Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy

Experimental group

Description:

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.

Treatment:

Biological: Placebo

Biological: JNJ-67670187