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| ID | Type | Description | Link |
|---|---|---|---|
| 54175446EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of JNJ-54175446 under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Treatment Sequence AB | Experimental | Participants will receive Treatment A [JNJ-54175446, 50 milligram (mg) capsule] on Day 1 of period 1 followed by Treatment B [JNJ-54175446, 50 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
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| Group 1: Treatment Sequence BA | Experimental | Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
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| Group 2: Treatment Sequence CD | Experimental | Participants will receive Treatment C [JNJ-54175446, 100 mg capsule] on Day 1 of period 1 followed by Treatment D [JNJ-54175446, 100 mg suspension] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
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| Group 2: Treatment Sequence DC | Experimental | Participants will receive Treatment D on Day 1 of period 1 followed by Treatment C on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54175446 (capsule) | Drug | Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-54175446 | The Cmax is the maximum observed plasma concentration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-54175446 | The Tmax is defined as actual sampling time to reach maximum plasma concentration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of JNJ-54175446 | The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-54175446 | 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(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Elimination Rate Constant (Lambda[z]) of JNJ-54175446 | Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Baseline up to 9 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| JNJ-54175446 (suspension) | Drug | Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally. |
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| Elimination Half-Life (t1/2) of JNJ-54175446 | The elimination half-life (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 is calculated as 0.693/lambda(z). | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| Relative Bioavailability of JNJ-54175446 | Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of capsule to suspension formulation). | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose |
| ID | Term |
|---|---|
| C000655225 | JNJ-54175446 |
| D002214 | Capsules |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
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