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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: JNJ-72537634; Biological: Placebo

• Registration Number: NCT03931447
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study Start: 2019-04-30
• Study First Posted: 2019-04-30
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD)	JNJ-72537634	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.
Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD)	JNJ-72537634	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.
Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD)	JNJ-72537634	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.
Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD)	Placebo	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.
Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD)	Placebo	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.
Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD)	Placebo	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.
Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)	Placebo	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.
Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)	JNJ-72537634	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.

Primary Outcome Measures

Name	Time	Method
Part 1 Single Day (SD) Dose: Percentage of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability	Up to 24 Weeks post final dose	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 24 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Part 1 SD: Number of Participants With Abnormalities in Vital Signs, Electrocardiogram (ECG) and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability	Up to 12 Weeks post final dose	Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.
Part 2 Multiple Day (MD) Dose: Percentage of Participants With TEAE and SAE as a Measure of Safety and Tolerability	Up to 26 Weeks post final dose	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 26 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Part 2 MD: Number of Participants With Abnormalities in Vital Signs, ECG and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability	Up to 14 Weeks post final dose	Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.

Secondary Outcome Measures

Name	Time	Method
Part 2: Detection and Abundance of JNJ-72537634	Up to 26 Weeks	Stool assessment will be done to characterize the presence of JNJ-72537634.
Part 1: Detection and Abundance of JNJ-72537634	Up to 24 Weeks	Stool assessment will be done to characterize the presence of JNJ-72537634.

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium