Healthy
Conditions
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.
Interventions
DRUGJNJ-77242113
JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vz/F) of JNJ-77242113 | Predose up to Day 3 | Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113. |
| Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113 | Predose up to Day 3 | AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113. |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113 | Predose up to Day 3 | Cmax is defined as maximum observed plasma concentration of JNJ-77242113. |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113 | Predose up to Day 3 | Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113. |
| Apparent Elimination Half-life (T1/2) of JNJ-77242113 | Predose up to Day 3 | T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113. |
| Apparent Total Systemic Clearance (CL/F) of JNJ-77242113 | Predose up to Day 3 | CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113. |
| Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113 | Predose up to Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) | Up to Day 35 | Number of participants with abnormalities in 12-lead ECGs will be reported. |
| Number of Participants with Abnormalities in Vital Signs | Up to Day 35 | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. |
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Up to Day 35 | Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported. |
| Number of Participants with Adverse Events (AEs) | Up to Day 35 | 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. |
| Number of Participants with Abnormalities in Physical Examinations | Up to Day 35 | Number of participants with abnormalities in physical examinations will be reported. |
Countries
China
Outcome results
None listed