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 (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.

• Androxal (Drug), also known as Enclomiphene citrate: 125 mg Androxal, 250 mg Androxal separated by at least 7 days
• Placebo (Drug), also known as Sugar pill: Placebo, single dose

Primary outcomes

• Pharmacokinetics [24 hrs]: Cmax of a single dose 125 mg of Androxal
• Cmax of a Single Dose of 250 mg Androxal [24 hours]

Sex: Male, ages: 18 Years to 60 Years, accepts healthy volunteers

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;

Participant flow

Outcome results

• Pharmacokinetics (Primary), Mean, ng/dL: Up to 250 mg Androxal 11.0 +/- 3.1
• Cmax of a Single Dose of 250 mg Androxal (Primary), Mean, ng/dL: Up to 250 mg Androxal 24.9 +/- 10.4

Adverse events

Time frame: Up to 24 hours after last dose of study drug

Other adverse events by term

• Joseph S Podolski, Study chair, Repros Therapeutics Inc.