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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pharmacokinetics, Tolerability

Intervention / Treatment
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* Drug: Androxal
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalting<br>Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose | Drug: Androxal<br>* 125 mg Androxal, 250 mg Androxal separated by at least 7 days<br>* Other names: Enclomiphene citrate;Drug: Placebo<br>* Placebo, single dose<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Cmax of a single dose 125 mg of Androxal | 24 hrs | 
| Cmax of a Single Dose of 250 mg Androxal |  | 24 hours |