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| ID | Type | Description | Link |
|---|---|---|---|
| 77242113PSO1004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-77242113 Dose 1 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1. |
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| Cohort 2: JNJ-77242113 Dose 2 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1. |
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| Cohort 3: JNJ-77242113 Dose 3 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 35 |
| Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100089 | China |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| 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 |
Number of participants with abnormalities in 12-lead ECGs will be reported.
| Up to Day 35 |
| 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 |
| 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 |
| 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 |