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

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02169804
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Aug 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics - The Cmax will be calculated. [4 days]

2. Pharmacokinetics - The Tmax will be calculated. [4 days]

3. Pharmacokinetics - The AUC0-24 will be calculated. [4 days]

4. Pharmacokinetics - the AUC0-∞ will be calculated. [4 days]

5. Pharmacokinetics - The t½ will be calculated. [4 days]

Secondary Outcome Measures

1. Safety - Incidence of adverse events [4 days]

2. Safety -Mean change from baseline in laboratory values [4 days]

3. Safety - Mean change from baseline in vital signs [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States

Sponsors and Collaborators

• Repros Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT02169804
• Other Study ID Numbers: ZA-111
• First Posted: Jun 23, 2014
• Last Update Posted: Oct 1, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Enclomiphene

Study Results

No Results Posted as of Oct 1, 2014