A PK and Safety Study in Subjects With Hepatic Impairment

Phase 1 Completed 32 enrolled Merck & Co., Inc.

Non-randomizedParallel-groupOpen-label

Summary

Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

Timeline

Start: 2011-08
Primary completion: 2012-05
Completion: 2012-05

Publications

Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tedizolid	Small molecule	200 mg	Oral

Indications

No indication recorded.