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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004167-39 | EudraCT Number | ||
| 54175446EDI1006 | Other Identifier | Janssen Research & Development, LLC |
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The main purpose of this study is to determine the potential inhibitory/inducing effects of JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9, CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Cocktail + JNJ-54175446 | Experimental | All subjects will receive a single dose of drug cocktail (consisting of midazolam [2 milligram (mg)], warfarin [10 mg], caffeine [50 mg], dextromethorphan [30 mg], bupropion [150 mg] and omeprazole [20 mg]) on Day 1, 7 and 11; JNJ-54175446 150 mg on Day 7, 9, 10 and 11 and JNJ-54175446 600 mg on Day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54175446 150 mg | Drug | Subjects will receive JNJ-54175446 150 mg capsules orally (1*100 mg + 1*50 mg) under fasted conditions on Day 7, 9, 10 and 11. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Up to Day 17 |
| Plasma Trough Concentration (Ctrough) | Ctrough is defined as observed plasma concentration of drug just prior to the beginning or at the end of a dosing interval. | Up to Day 17 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed concentration. | Up to Day 17 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) | The AUClast is the area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit) concentration. | Up to Day 17 |
| 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(last) and C(last)/lambda(z); wherein AUC(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. | Up to Day 17 |
| Elimination Rate Constant (Lambda [z]) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) as a Measure of Safety and Tolerability | Safety and Tolerability | Up to follow up (14 to 21 days after last dose) |
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Inclusion 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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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| JNJ-54175446 600 mg | Drug | Subjects will receive JNJ-54175446 600 mg (6*100 mg capsules) orally on Day 8. |
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| Midazolam 2 mg | Drug | Subjects will receive midazolam 2 mg oral emulsion [2 (milligram per milliliter (mg/mL)] as a drug cocktail on Day 1, 7 and 11. |
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| Warfarin 10 mg | Drug | Subjects will receive warfarin 10 mg tablets (2*5 mg) orally as a drug cocktail on Day 1, 7 and 11. |
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| Caffeine 50 mg | Drug | Subjects will receive caffeine 50 mg tablet (1*50 mg) orally as a drug cocktail on Day 1, 7 and 11. |
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| Dextromethorphan 30 mg | Drug | Subjects will receive dextromethorphan 30 mg capsule (1*30 mg) orally as a drug cocktail on Day 1, 7 and 11. |
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| Bupropion 150 mg | Drug | Subjects will receive Bupropion 150 mg tablet (1*150 mg) orally as a drug cocktail on Day 1, 7 and 11. |
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| Omeprazole 20 mg | Drug | Subjects will receive omeprazole 20 mg capsule (1*20 mg) orally as a drug cocktail on Day 1, 7 and 11. |
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| Up to Day 17 |
| Elimination Half-Life (t1/2) | 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). | Up to Day 17 |
| Apparent Total Clearance (CL/F) | Apparent total clearance is calculated as dose/AUC(0-infinity). | Up to Day 17 |
| Apparent Volume of Distribution (Vd/F) | Apparent volume of distribution, calculated as dose/(lambda[z]*AUC[0-infinity]). | Up to Day 17 |
| Parent to Metabolite Ratio (Cmax) | Parent to metabolite ratio Cmax is defined as the ratio of individual Cmax values between parent and metabolite. | Up to Day 17 |
| Parent to Metabolite Ratio (AUC [Last]) | Parent to metabolite ratio (AUC [Last]) is defined as ratio of individual (AUC [Last]) values between parent and metabolite. | Up to Day 17 |
| Parent to Metabolite Ratio (AUC [infinity]) | Parent to Metabolite Ratio (AUC [infinity]) is defined as the ratio of individual (AUC [infinity]) values between parent and metabolite. | Up to Day 17 |
| ID | Term |
|---|---|
| C000655225 | JNJ-54175446 |
| D008874 | Midazolam |
| D014859 | Warfarin |
| D002110 | Caffeine |
| D003915 | Dextromethorphan |
| D016642 | Bupropion |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
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