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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-77242113

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100089
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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; JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.; Other Names: PN-235; PN-21235
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; JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.; Other Names: PN-235; PN-21235
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; JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.; Other Names: PN-235; PN-21235

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR109263; 77242113PSO1004 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No