Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Phase 1 Completed 16 enrolled Mylan Inc. Theravance Biopharma · collab

Non-randomizedParallel-groupOpen-labelBasic science

Summary

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.

Timeline

Start: 2015-11
Primary completion: 2016-04
Completion: 2016-04

Publications

Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Revefenacin	Small molecule	175 ug	Inhaled

Indications

No indication recorded.