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

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;