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Completed

NCT Number: NCT03931447

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-72537634

Biological

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.

Placebo

Biological

Participants will receive matching placebo as oral capsule in all cohorts.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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