Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 42165279EDI1004 | Other Identifier | Janssen Pharmaceutica N.V., Belgium |
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 this study is to assess the effects of repeated administration of 200 mg of itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male participants.
This is an open-label (all people know the identity of the intervention), study in healthy male participants. This study will consist of a screening phase (between 21 and 2 days prior to the first dose administration of JNJ-42165279), a 2-period (Period 1: Day 1 to Day 3 and Period 2: Day 4 to Day 10) open-label treatment phase, and a follow-up phase (within 7 to 14 days after the last dose of JNJ-42165279). A single 30-mg dose of JNJ-42165279 will be administered on Day 1 of Period 1. During Period 2, the administration of oral itraconazole 200 mg once a day will start on Day 4. A second single oral 30-mg dose of JNJ-42165279 will be administered on Day 8 together with the dose of 200 mg itraconazole. Sixteen healthy participants will be enrolled in this study. Safety assessments will include assessment of adverse events, supine vital signs, 12-lead electrocardiogram, clinical laboratory testing and physical examinations. The maximum study duration for each participant will be approximately 7 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Participants will receive a single 30-mg dose of JNJ-42165279 on Day 1. |
|
| Period 2 | Experimental | Participants will receive itraconazole 200 mg once a day from Day 4 to Day 10. A single oral 30-mg dose of JNJ-42165279 will be administered on Day 8 along with the dose of 200 mg itraconazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42165279 | Drug | Participants will receive a single 30-mg (6 mL of oral suspension) dose of JNJ-42165279 orally (by mouth) on Day 1 (Period 1) and on Day 8 (Period 2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-42165279 | The Cmax is defined as maximum observed analyte concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42165279 | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUCt) of JNJ-42165279 | AUCt is area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])of JNJ-42165279 | The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to Week 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
Not provided
| ID | Term |
|---|---|
| C000632387 | JNJ-42165279 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Itraconazole | Drug | Participants will receive itraconazole 200 mg (2 capsules) once a day orally on Days 4, 5, 6, 7, 8, 9, and 10 (Period 2). |
|
| Terminal Rate Constant (Lambda[z]) of JNJ-42165279 | Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Elimination Half-Life Period (T1/2) of JNJ-42165279 | The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| Relative Bioavailability (Frel) of JNJ-42165279 | Relative bioavailability is the percentage of the administered dose that is systemically available. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 |
| D010879 |
| Piperazines |