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

NCT ID: NCT05062200

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-09-28

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered as an oral tablet.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as an oral tablet.

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.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered as an oral tablet.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as an oral tablet.

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.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered as an oral tablet.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as an oral tablet.

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.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered as an oral tablet.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as an oral tablet.

Interventions

JNJ-77242113

JNJ-77242113 will be administered as an oral tablet.

Intervention Type: DRUG

Placebo

Matching placebo will be administered as an oral tablet.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Souseikai Hakata Clinic

Fukuoka, , Japan

Countries

Japan

Other Identifiers

77242113PSO1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR109097

Identifier Type: -

Identifier Source: org_study_id