Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

Study Overview
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Brief Summary
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This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.

Official Title
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AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL

Conditions
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Normal Volunteers

Intervention / Treatment
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* Drug: Androxal 25 mg Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures; Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive 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 for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit) Must be able to swallow gelatin capsules; Must be willing to remain in the clinic for the treatment visits Exclusion Criteria: Known hypersensitivity to Clomid; Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator; A hematocrit >54% or a hemoglobin >17 g/dL. 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; 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; Known history of HIV and/or Hepatitis B or C Tobacco (nicotine products) use in the 3 months prior to the study; 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; Previous participation in a clinical study of Androxal.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androxal 25 mg<br> | Drug: Androxal 25 mg Capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state. |  | 24 hour |