Clinical trial NCT05703841: A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Apparent Elimination Half-life (T1/2) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Apparent Total Systemic Clearance (CL/F) of JNJ-77242113
timeFrame: Predose up to Day 3
measure: Apparent Volume of Distribution (Vz/F) of JNJ-77242113
timeFrame: Predose up to Day 3
Secondary outcomes:
measure: Number of Participants with Abnormalities in Physical Examinations
timeFrame: Up to Day 35
measure: Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)
timeFrame: Up to Day 35
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Day 35
measure: Number of Participants with Abnormalities in Clinical Laboratory Tests
timeFrame: Up to Day 35
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 35
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: