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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-77242113

• Registration Number: NCT05703841
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Study Start: 2023-02-14
• Primary Completion: 2023-04-07
• Study Completion: 2023-04-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: JNJ-77242113 Dose 1	JNJ-77242113	Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1.
Cohort 3: JNJ-77242113 Dose 3	JNJ-77242113	Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1.
Cohort 2: JNJ-77242113 Dose 2	JNJ-77242113	Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1.

Primary Outcome Measures

Name	Time	Method
Apparent Volume of Distribution (Vz/F) of JNJ-77242113	Predose up to Day 3	Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.
Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113	Predose up to Day 3	Cmax is defined as maximum observed plasma concentration of JNJ-77242113.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113	Predose up to Day 3	AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to time of the last measurable concentration of JNJ-77242113.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113	Predose up to Day 3	AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113	Predose up to Day 3	Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.
Apparent Elimination Half-life (T1/2) of JNJ-77242113	Predose up to Day 3	T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.
Apparent Total Systemic Clearance (CL/F) of JNJ-77242113	Predose up to Day 3	CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Abnormalities in Physical Examinations	Up to Day 35	Number of participants with abnormalities in physical examinations will be reported.
Number of Participants with Abnormalities in Vital Signs	Up to Day 35	Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Number of Participants with Abnormalities in Clinical Laboratory Tests	Up to Day 35	Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported.
Number of Participants with Adverse Events (AEs)	Up to Day 35	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)	Up to Day 35	Number of participants with abnormalities in 12-lead ECGs will be reported.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China