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

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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

Key facts

Study ID

NCT02169804

Run by

Repros Therapeutics Inc.

People needed

24

Starts

2014-08-01

Expected to finish

2014-08-01

Last updated by the study team

2014-10-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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