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An Open-Label, Randomized, Parallel-Group Drug-Drug Interaction Study to Assess the Effect of Multiple Doses of Itraconazole or Gemfibrozil on the Pharmacokinetics of a Single Dose of JNJ-56021927 in Healthy Male Subjects
The purpose of this study is to assess the effect of multiple doses of itraconazole or gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021) in healthy male participants.
Details
| Lead sponsor | Aragon Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2014-09 |
| Completion | 2014-12 |
Conditions
- Healthy
Interventions
- JNJ-56021927
- Itraconazole
- Gemfibrozil
Primary outcomes
- Maximum Plasma Concentration (Cmax) — Up to Day 57 or Day 60
The Cmax is the maximum observed plasma concentration. Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C). - Time to Reach Maximum Concentration (tmax) — Up to Day 57 or Day 60
The tmax is time to reach the maximum observed plasma concentration. Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C). - Area Under the Plasma Concentration-Time Curve From Time Zero to 672 Hours (AUC [0-672]) — Up to Day 57 or Day 60
The AUC (0-672) is the area under the plasma concentration-time curve from time zero to 672 hours. Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C). - Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) — Up to Day 57 or Day 60
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C). - Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) — Up to Day 57 or Day 60
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. Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C). - Percentage of Extrapolated AUC (0-infinity) — Up to Day 57 or Day 60
The percentage of AUC (0-infinity) that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC\_%extrapolation = 100\*(AUC \[0-infinity\] minus (AUC \[0-last\])/(AUC (0-infinity). Blood samples will be collected up to Day 57 (for Treatment A) or Day 60 (for Treatment B and C).
Countries
United States