Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

Phase 1/2 Completed 137 enrolled Millennium Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

Timeline

Start: 2012-08-20
Primary completion: 2013-09-12
Completion: 2016-09-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orteronel	Small molecule	200 mg	Oral
Subject	Orteronel	Small molecule	300 mg	Oral
Subject	Orteronel	Small molecule	400 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

Summary

Timeline

Drugs

Indications