An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

Study Overview
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Brief Summary
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• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.

Official Title
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An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Androxal 25 mg


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 <60 or ≥70 years of age 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 one overnight treatment visit after the 3rd dose of Androxal (approximately 36 hours for the treatment visit) 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; 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

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 70 years or older<br>Non-smoking healthy adult males >or equal to 70 years of age. | Drug: Androxal 25 mg<br> <br> |
| Experimental: Under 60 years of age<br>Non-smoking healthy adult males<60 years of age. | Drug: Androxal 25 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - The Cmax will be calculated. |  | 4 days | 
| Pharmacokinetics - The Tmax will be calculated. |  | 4 days | 
| Pharmacokinetics - The AUC0-24 will be calculated. |  | 4 days | 
| Pharmacokinetics - the AUC0-∞ will be calculated. |  | 4 days | 
| Pharmacokinetics - The t½ will be calculated. |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Incidence of adverse events |  | 4 days | 
| Safety -Mean change from baseline in laboratory values |  | 4 days | 
| Safety - Mean change from baseline in vital signs |  | 4 days |