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NCT05703841 | Completed | Healthy


A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
Sponsor:

Janssen Research & Development, LLC

Brief Summary:

The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.

Condition or disease

Healthy

Intervention/treatment

JNJ-77242113

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
Actual Study Start Date : February 14, 2023
Estimated Primary Completion Date : April 7, 2023
Estimated Study Completion Date : April 12, 2023
Arm Intervention/treatment

Experimental: Cohort 1: JNJ-77242113 Dose 1

Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1.

Drug: JNJ-77242113

Experimental: Cohort 2: JNJ-77242113 Dose 2

Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1.

Drug: JNJ-77242113

Experimental: Cohort 3: JNJ-77242113 Dose 3

Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1.

Drug: JNJ-77242113

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Body mass index (BMI; weight kilograms [kg] per height [meter^2]) between 18.0 and 27.9 kilograms per meter^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and on Day -1
  • Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
  • Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration
Exclusion Criteria
  • History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
  • History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
  • Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
  • Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
  • History of severe allergic or anaphylactic reactions

A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

Location Details


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A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

How to Participate

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Locations


Not yet recruiting

China,

Peking University Third Hospital

Beijing, China, 100089

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