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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169804
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Androxal 25 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
Study Start Date : August 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Pharmacokinetics - The Cmax will be calculated. [ Time Frame: 4 days ]
  2. Pharmacokinetics - The Tmax will be calculated. [ Time Frame: 4 days ]
  3. Pharmacokinetics - The AUC0-24 will be calculated. [ Time Frame: 4 days ]
  4. Pharmacokinetics - the AUC0-∞ will be calculated. [ Time Frame: 4 days ]
  5. Pharmacokinetics - The t½ will be calculated. [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Safety - Incidence of adverse events [ Time Frame: 4 days ]
  2. Safety -Mean change from baseline in laboratory values [ Time Frame: 4 days ]
  3. Safety - Mean change from baseline in vital signs [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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;
  2. Male; age <60 or ≥70 years of age
  3. No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
  4. Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
  5. 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)
  6. Must be able to swallow gelatin capsules

Exclusion Criteria:

  1. Known hypersensitivity to Clomid;
  2. Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
  3. A hematocrit >54% or a hemoglobin >17 g/dL.
  4. Subject with a significant organ abnormality or disease as determined by the Investigator;
  5. Any medical condition that would interfere with the study as determined by the Investigator;
  6. Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
  7. An acute illness within 5 days of study medication administration;
  8. Positive urine drug screen at the screening visit;
  9. Known history of HIV and/or Hepatitis B or C
  10. Tobacco (nicotine products) use in the 3 months prior to the study;
  11. 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;
  12. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
  13. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
  14. An employee or family member of an employee of the study site or the Sponsor;
  15. Previous participation in a clinical study of Androxal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02169804

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United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Repros Therapeutics Inc.
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT02169804    
Other Study ID Numbers: ZA-111
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators