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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT05062200

CR109097

77242113PSO1002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 4 patient groups

Cohort 1: JNJ-77242113 or Placebo (Single Ascending Dose [SAD])

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Cohort 2: JNJ-77242113 or Placebo (SAD)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Cohort 3: JNJ-77242113 or Placebo (Single Dose [SD])

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Cohort 4: JNJ-77242113 or Placebo (SD)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Drug: Placebo