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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT05703841

77242113PSO1004 (Other Identifier)

CR109263

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Cohort 1: JNJ-77242113 Dose 1

Experimental group

Description:

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

Treatment:

Drug: JNJ-77242113

Cohort 2: JNJ-77242113 Dose 2

Experimental group

Description:

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

Treatment:

Drug: JNJ-77242113

Cohort 3: JNJ-77242113 Dose 3

Experimental group

Description:

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

Treatment:

Drug: JNJ-77242113