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| ID | Type | Description | Link |
|---|---|---|---|
| 42756493EDI1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-002634-31 | EudraCT Number |
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The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg) dose as an oral solution administered in combination with a single intravenous administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a tablet (test) formulation in a crossover (method used to switch subjects from one study group to another in a clinical trial) design in healthy participants.
This is a randomized (study drug assigned by chance), open-label (all people know the identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study of oral JNJ-42756493 in healthy participants. The duration of the study is approximately 36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout and 12-14-day follow-up (Day 13-15 of period 2). All participants will be randomly assigned to 1 of 2 treatment sequences. In Treatment Sequence AB: JNJ-42756493 10 mg tablet formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and 10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12 days washout is required between treatment periods. Participants will primarily be analyzed for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2. |
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| Treatment Sequence BA | Experimental | Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42756493 10 mg tablet | Drug | Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability: Maximum Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration of JNJ-42756493. | Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose |
| Absolute Bioavailability | Absolute bioavailability will be measured by Area under concentration time-curve (AUC [0-24]), AUC (0-last) and AUC (0-infinity). | Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose |
| Relative Bioavailability: Area under concententration time-curve (AUC) | Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity). | Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Concentration (tmax) | The tmax is time to reach the maximum observed plasma concentration. | Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose |
| Elimination Half-Life (t1/2) |
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| ID | Term |
|---|---|
| C000604580 | erdafitinib |
| D013607 | Tablets |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| JNJ-42756493 10 mg Oral Solution | Drug | Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2. |
|
| JNJ-61818549 | Drug | Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1. |
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Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. |
| Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose |