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

• ClinicalTrials.gov Identifier: NCT03931447
• Recruitment Status: Completed
• First Posted: April 30, 2019
• Last Update Posted: March 25, 2020
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Biological: JNJ-72537634; Biological: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study To Assess The Safety And Tolerability Of JNJ-72537634 In Healthy Participants
• Actual Study Start Date: April 30, 2019
• Actual Primary Completion Date: February 10, 2020
• Actual Study Completion Date: February 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Biological: 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.; Biological: Placebo; Participants will receive matching placebo as oral capsule in all cohorts.
Experimental: 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.	Biological: 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.; Biological: Placebo; Participants will receive matching placebo as oral capsule in all cohorts.
Experimental: 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.	Biological: 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.; Biological: Placebo; Participants will receive matching placebo as oral capsule in all cohorts.
Experimental: 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.	Biological: 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.; Biological: Placebo; Participants will receive matching placebo as oral capsule in all cohorts.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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.
2. Part 2 Multiple Day (MD) Dose: Percentage of Participants With TEAE and SAE as a Measure of Safety and Tolerability [ Time Frame: 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.
3. 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 [ Time Frame: Up to 12 Weeks post final dose ]
   Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.
4. Part 2 MD: Number of Participants With Abnormalities in Vital Signs, ECG and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Belgium

Clinical Pharmacology Unit

Merksem, Belgium, 2170

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03931447
• Other Study ID Numbers: CR108615; 72537634IBD1001 ( Other Identifier: Janssen Research & Development, LLC ); 2018-003700-39 ( EudraCT Number )
• First Posted: April 30, 2019
• Last Update Posted: March 25, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No