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| ID | Type | Description | Link |
|---|---|---|---|
| 54416076EDI1002 | Other Identifier | Janssen Research & Development, LLC |
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JNJ-54416076 program has been stopped for strategic business reasons.
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The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment Sequence A1B1C1 | Experimental | Participants in Part 1 will only receive single dose of Treatment A1 oral Suspension (25 milligram [mg], Fasted) then Treatment B1 (Direct Compression Tablets, 5*5 mg Tablets, Fasted) followed by Treatment C1 (Direct Compression Tablets (5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 1: Treatment Sequence B1C1A1 | Experimental | Participants in Part 1 will only receive single dose of Treatment B1 then Treatment C1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 1: Treatment Sequence C1A1B1 | Experimental | Participants in Part 1 will only receive single dose of Treatment C1 then Treatment A1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 1: Treatment Sequence A1C1B1 | Experimental | Participants in Part 1 will only receive single dose of Treatment A1 then Treatment C1 followed by Treatment B1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54416076 (Oral Suspension) | Drug | Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Analyte Concentration (Cmax) | Cmax is the maximum observed analyte concentration. | Predose up to Day 4 |
| Time to Reach Maximum Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Predose up to Day 4 |
| Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last]) | Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation. | Predose up to Day 4 |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Predose up to Day 4 |
| Apparent Terminal Elimination Half-life (t1/2term) | The elimination halflife (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 slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]). | Predose up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 5 to 7 days after discharge (Follow-Up Phase ) |
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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 |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Part 1: Treatment Sequence B1A1C1 | Experimental | Participants in Part 1 will only receive single dose of Treatment B1 then Treatment A1 followed by Treatment C1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 1: Treatment Sequence C1B1A1 | Experimental | Participants in Part 1 will only receive single dose of Treatment C1 then Treatment B1 followed by Treatment A1 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence A2B2C2 | Experimental | Participants in Part 2 will only receive single dose of Treatment A2 oral Suspension (25 mg, Fasted) then Treatment B2 (Fluid Bed Granulation Tablets (5*5 mg Tablets, Fasted) followed by Treatment C2 (Fluid Bed Granulation Tablets, 5*5 mg Tablets, Fed) on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence B2C2A2 | Experimental | Participants in Part 2 will only receive single dose of Treatment B2 then Treatment C2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence C2A2B2 | Experimental | Participants in Part 2 will only receive single dose of Treatment C2 then Treatment A2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence A2C2B2 | Experimental | Participants in Part 2 will only receive single dose of Treatment A2 then Treatment C2 followed by Treatment B2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence B2A2C2 | Experimental | Participants in Part 2 will only receive single dose of Treatment B2 then Treatment A2 followed by Treatment C2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| Part 2: Treatment Sequence C2B2A2 | Experimental | Participants in Part 2 will only receive single dose of Treatment C2 then Treatment B2 followed by Treatment A2 on Day 1 of the treatment period (Days 1 to 4). Successive treatment periods will be separated by a washout period of 14 days (+/- 1 day). |
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| JNJ-54416076 (Formulation 1: Direct Compression Tablets) | Drug | Participants will receive JNJ-54416076 Tablet formulation 1 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 1. |
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| JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets) | Drug | Participants will receive JNJ-54416076 Tablet formulation 2 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 2. |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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