Pharmacokinetics and tolerability of the new second-generation nonnucleoside reverse- transcriptase inhibitor KM-023 in healthy subjects.

ABSTRACT:

Background

KM-023 is a new second-generation nonnucleoside reverse-transcriptase inhibitor that is under development for the treatment of human immunodeficiency virus (HIV) type 1 infection.

Objective

This study determined KM-023 tolerability and pharmacokinetic characteristics in healthy subjects.

Materials and methods

A randomized, double-blinded, placebo-controlled, dose-escalation study was conducted in 80 healthy South Korean male volunteers. The subjects were allocated to single- or multiple-dose (once daily for 7 days) groups that received 75, 150, 300, or 600 mg drug or placebo in a 4:1 ratio. Safety and pharmacokinetic assessments were performed during the study. Plasma and urine concentrations were quantified using liquid chromatography-tandem mass spectrome

SUBMITTER: Cha YJ 

PROVIDER: S-EPMC4189701 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature