drugset
drugset / Trial / NCT02592317

A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer

NCT02592317 ↗

Phase 1 Active not recruiting 23 enrolled Aragon Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2C8) and transporter (P-gp and BRCP) substrates in participants with castration-resistant prostate cancer (CRPC).

Timeline

Start
2016-02-12
Primary completion
2016-11-07
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Subject Fexofenadine Unknown 30 mg Oral
Subject Midazolam Small molecule 2 mg Oral
Subject Omeprazole Other / unclassified 40 mg Oral
Subject Pioglitazone Small molecule 15 mg Oral
Subject Rosuvastatin Small molecule 15 mg Oral
Subject Vitamin K Unknown 10 mg Oral
Subject Warfarin Small molecule 10 mg Oral

Indications

castration-resistant prostate carcinoma