A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers

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.

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.

Inclusion Criteria:

• Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
• Male, between the ages of 18-60 years;
• No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
• Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
• Subject is willing to remain in the clinic overnight for the Day 1 and Day 8 visits;
• Must be able to swallow gelatin capsules

Exclusion Criteria:

• Known hypersensitivity to Clomid;
• Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
• Subject with a significant organ abnormality or disease as determined by the Investigator;
• Any medical condition that would interfere with the study as determined by the Investigator;
• Slow cytochrome P450 2D6 (CYP2D6) metabolizer
• Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
• An acute illness within 5 days of study medication administration;
• Positive urine drug screen at the screening visit;
• A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
• History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
• History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
• An employee or family member of an employee of the study site or the Sponsor;