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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931447
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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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

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931447


Locations
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Belgium
Clinical Pharmacology Unit
Merksem, Belgium, 2170
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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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    Key Record Dates
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

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