Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 42396302EDI1003 | Other Identifier | Janssen-Cilag International NV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants.
This is a phase I, open-label (all people know the identity of the intervention) and parallel-group (each group of patients will be treated at the same time), randomized (the study medication is assigned by chance) study in healthy male participants, to investigate the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first dose of study medication), a treatment phase, and a follow up phase. In the treatment phase, participants will be divided into 3 treatment groups with 6 participants each, to receive a single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be approximately 4 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42396302 | Experimental | Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
|
| JNJ-42692507 | Experimental | Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
|
| JNJ-53773187 | Experimental | Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42396302 | Drug | A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Area under the plasma concentration time curve for JNJ-42396302 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Apparent terminal elimination half-life of JNJ-42396302 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Area under the plasma concentration time curve for JNJ-53773187 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Apparent terminal elimination half-life of JNJ-53773187 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | within 7 days after the last dose of the study medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JNJ-42692507 | Drug | A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. |
|
| JNJ-53773187 | Drug | A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. |
|
| Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507 |
| 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours |
| Area under the plasma concentration time curve for JNJ-42692507 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours |
| Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours |
| Apparent terminal elimination half-life of JNJ-42692507 | 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours |