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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: JNJ-72537634

Study type: Interventional

Funder types: Industry

Identifiers

NCT03931447

72537634IBD1001 (Other Identifier)

2018-003700-39 (EudraCT Number)

CR108615

Details and patient eligibility

About

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.

Enrollment: 31 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) (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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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31 participants in 4 patient groups

Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-72537634

Biological: Placebo

Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-72537634

Biological: Placebo

Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-72537634

Biological: Placebo

Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-72537634

Biological: Placebo