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

NCT ID: NCT05703841

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2023-04-12

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: JNJ-77242113 Dose 1

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

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Cohort 2: JNJ-77242113 Dose 2

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

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Cohort 3: JNJ-77242113 Dose 3

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

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Interventions

JNJ-77242113

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Intervention Type: DRUG

Other Intervention Names

PN-21235; PN-235

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

77242113PSO1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR109263

Identifier Type: -

Identifier Source: org_study_id