drugset
drugset / Trial / NCT01932320

A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813

NCT01932320 ↗

Phase 1 Completed 36 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the rate and extent of absorption of a single dose of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).

Timeline

Start
2010-02
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject JNJ-40411813 Small molecule 50 mg Oral
Subject JNJ-40411813 Small molecule 100 mg Oral
Subject JNJ-40411813 Small molecule 150 mg Oral
Background Ketoconazole Small molecule 200 mg Oral

Indications

No indication recorded.