A Study of JNJ-77242113 in Healthy Japanese and Chinese Participants

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-77242113 in Healthy Japanese Participants and a Single Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-77242113 in Healthy Chinese Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR) tablet formulation in healthy Japanese participants and after single oral dose administration as an IR tablet formulation in healthy Chinese participants; and as a delayed release (DR) tablet formulation in healthy Japanese participants.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Souseikai Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• For Parts 1 and 3: Japanese male or female of non-childbearing potential, who have parents and maternal and paternal grandparents who are of Japanese ethnicity
• For Part 2: Chinese male or female of non-childbearing potential, who have parents and maternal and paternal grandparents who are of Chinese ethnicity
• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
• Body weight not less than 50 kilograms (kg) and body mass index within the range 18 and 30 kilograms per meter square (kg/m^2) (inclusive)
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

• History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
• Use of a live vaccine within 30 days prior to screening or anticipated need for a live vaccine during the study or for 30 days following the dose of study drug
• Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the dose of the study intervention is scheduled
• Test positive for human immunodeficiency virus (HIV)-1 and 2 antigen/antibodies, test positive for hepatitis C antibodies, test positive for syphilis, or test positive for hepatitis B virus (HBV) infection at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: JNJ-77242113 or Placebo (Single Ascending Dose [SAD]); Japanese participants will receive single oral dose 1 of JNJ-77242113 (immediate-release [IR] tablet) or matching placebo on Day 1 in Cohort 1 of Part 1.	Drug: JNJ-77242113; JNJ-77242113 will be administered as an oral tablet.; Drug: Placebo; Matching placebo will be administered as an oral tablet.
Experimental: Cohort 2: JNJ-77242113 or Placebo (SAD); Japanese participants will receive single oral dose 2 of JNJ-77242113 (IR tablet) or matching placebo on Day 1 in Cohort 2 of Part 1.	Drug: JNJ-77242113; JNJ-77242113 will be administered as an oral tablet.; Drug: Placebo; Matching placebo will be administered as an oral tablet.
Experimental: Cohort 3: JNJ-77242113 or Placebo (Single Dose [SD]); Chinese participants will receive single oral dose 2 of JNJ-77242113 (IR tablet) or matching placebo on Day 1 in Cohort 3 of Part 2.	Drug: JNJ-77242113; JNJ-77242113 will be administered as an oral tablet.; Drug: Placebo; Matching placebo will be administered as an oral tablet.
Experimental: Cohort 4: JNJ-77242113 or Placebo (SD); Japanese participants will receive single oral dose 3 of JNJ-77242113 (delayed-release [DR] tablet) with absorption enhancer (AbE) or matching placebo on Day 1 in Cohort 4 of Part 3.	Drug: JNJ-77242113; JNJ-77242113 will be administered as an oral tablet.; Drug: Placebo; Matching placebo will be administered as an oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1, 2 and 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 6 weeks
Parts 1, 2 and 3: Plasma Concentration of JNJ-77242113	Plasma samples will be analyzed to determine concentrations of JNJ-77242113 using a validated, specific and sensitive method.	Predose up to 48 hours postdose (Up to Day 3)

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CR109097; 77242113PSO1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

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