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

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02146391
• Collaborator: (none)
• Enrollment: 12
• Arm: 1
• Duration (Days): 30

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Volunteers	Drug: Androxal 25 mg Capsules	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Androxal 25 mg	Drug: Androxal 25 mg Capsules

Outcome Measures

Primary Outcome Measures

1. • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state. [24 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• 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 18-60 with a BMI of 25-42 kg/m2 inclusive

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 2 overnight treatment visits (approximately 36 hours for the treatment visit)

6. Must be able to swallow gelatin capsules;

7. Must be willing to remain in the clinic for the treatment visits

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

No locations specified.

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: NCT02146391
• Other Study ID Numbers: ZA-107
• First Posted: May 23, 2014
• Last Update Posted: Aug 11, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Enclomiphene

Study Results

No Results Posted as of Aug 11, 2014