Conditions: Pharmacokinetics Tolerability
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: yes

Brief summary:
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Detailed description:
A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Arms:
arm 1: Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose

Interventions: intervention 1: Androxal intervention 2: Placebo
Intervention descriptions: intervention 1: 125 mg Androxal, 250 mg Androxal separated by at least 7 days intervention 2: Placebo, single dose

Protocol document: