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

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

February 12, 2016

Primary Completion Date

November 7, 2016

Study Completion Date

October 9, 2024

Conditions
Prostatic Neoplasms, Castration-Resistant
Interventions
DRUG

JNJ 56021927

JNJ 56021927 will be administered once daily orally in a dose of 240 mg from Study Day 15 up to disease progression, unacceptable toxicity, withdrawal of consent, lost to follow-up, the participant is no longer receiving clinical benefit in the opinion of the Investigator, the start of subsequent anticancer therapy, or the Sponsor ends the study.

DRUG

Drug Cocktail

Drug cocktail comprise of midazolam (2 mg), warfarin (10 mg), vitamin K (10 mg), omeprazole (40 mg), and fexofenadine (30 mg) will be administered on Study Day 1 and 43.

DRUG

Pioglitazone

Pioglitazone 15 mg will be administered orally on Study Day 8 and 50.

DRUG

Rosuvastatin

Rosuvastatin 15 mg will be administered orally on Study Day 9 and 51.

Trial Locations (3)

Unknown

Chisinau

Barcelona

Seville

Sponsors
All Listed Sponsors
lead

Aragon Pharmaceuticals, Inc.

INDUSTRY