Absorption, Distribution, and Excretion of the Investigational Agent Orteronel (TAK-700) in Healthy Male Subjects: A Phase 1, Open-Label, Single-Dose Study

• Published in: Clinical pharmacology in drug development Vol. 5; no. 3; pp. 180 - 187
• Main Authors: Suri, Ajit, Pusalkar, Sandeepraj, Li, Yuexian, Prakash, Shimoga
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.05.2016; Wiley Subscription Services, Inc
• Subjects: absorption; Adult; Area Under Curve; Chromatography, Liquid; Cytochrome P-450 Enzyme Inhibitors - adverse effects; Cytochrome P-450 Enzyme Inhibitors - pharmacokinetics; distribution; excretion; Half-Life; Humans; Imidazoles - adverse effects; Imidazoles - pharmacokinetics; Male; metastatic castration-resistant prostate cancer; Naphthalenes - adverse effects; Naphthalenes - pharmacokinetics; orteronel; Steroid 17-alpha-Hydroxylase - antagonists & inhibitors; Tandem Mass Spectrometry; Young Adult; metastatic castration-resistant prostate cancer; excretion; distribution; absorption; orteronel

This study evaluated the absorption, distribution, and excretion of orteronel, an investigational, nonsteroidal, reversible, selective 17,20‐lyase inhibitor. Six healthy male subjects received a single 400‐mg dose of radiolabeled [14C]‐orteronel (18.5 kBq). The pharmacokinetics of [14C]‐radioactivit...