A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects

Summary

This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and the positive control. In each Treatment Period subjects will be admitted to a Clinical Research Unit where study drug will be administered as three (3) daily single doses. Treatment Periods will be separated by a washout of at least 7 days between Periods.

Timeline

Start

2014-04

Primary completion

2014-05

Completion

—

Drugs

Indications

No indication recorded.