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

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

Official Title
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An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-77242113


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: JNJ-77242113 Dose 1<br>Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1. | Drug: JNJ-77242113<br>* JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.<br>* Other names: PN-235;|
| Experimental: Cohort 2: JNJ-77242113 Dose 2<br>Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1. | Drug: JNJ-77242113<br>* JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.<br>* Other names: PN-235;|
| Experimental: Cohort 3: JNJ-77242113 Dose 3<br>Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1. | Drug: JNJ-77242113<br>* JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.<br>* Other names: PN-235;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 35 | 
| Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) | Number of participants with abnormalities in 12-lead ECGs will be reported. | Up to Day 35 | 
| Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. | Up to Day 35 | 
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported. | Up to Day 35 | 
| Number of Participants with Adverse Events (AEs) | 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. | Up to Day 35 |