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

NCT05703841 | Completed Phase 1

• 2 other identifiers: CR10926377242113PSO1004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Number of Participants with Abnormalities in Physical Examinations

  Up to Day 35

• Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)

  Up to Day 35

• Number of Participants with Abnormalities in Vital Signs

  Up to Day 35

• Number of Participants with Abnormalities in Clinical Laboratory Tests

  Up to Day 35

• Number of Participants with Adverse Events (AEs)

  Up to Day 35

Study Arms (3)

Cohort 1: JNJ-77242113 Dose 1

EXPERIMENTAL

Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1.

Drug: JNJ-77242113

Cohort 2: JNJ-77242113 Dose 2

EXPERIMENTAL

Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1.

Drug: JNJ-77242113

Cohort 3: JNJ-77242113 Dose 3

EXPERIMENTAL

Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1.

Drug: JNJ-77242113

Interventions

JNJ-77242113 DRUG

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Also known as: PN-21235, PN-235

Cohort 1: JNJ-77242113 Dose 1; Cohort 2: JNJ-77242113 Dose 2; Cohort 3: JNJ-77242113 Dose 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100089, China

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: February 14, 2023
• Primary Completion: April 7, 2023
• Study Completion: April 12, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)