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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05703841
• Other study ID #: CR109263
• Secondary ID: 77242113PSO1004
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2023
• Est. completion date: April 12, 2023

Study information

• Verified date: June 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 12, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113	Cmax is defined as maximum observed plasma concentration of JNJ-77242113.	Predose up to Day 3
Primary	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
Primary	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
Primary	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
Primary	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	Number of Participants with Abnormalities in Physical Examinations	Number of participants with abnormalities in physical examinations will be reported.	Up to Day 35
Secondary	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
Secondary	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
Secondary	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
Secondary	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