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

NCT ID: NCT02146391

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Normal Volunteers

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Androxal 25 mg

Group Type: EXPERIMENTAL

Androxal 25 mg Capsules

Intervention Type: DRUG

Interventions

Androxal 25 mg Capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZA-107

Identifier Type: -

Identifier Source: org_study_id