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

Normal Volunteers Clinical Trial

Official title:

AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146391
• Other study ID #: ZA-107
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2014
• Last updated: August 7, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Normal Volunteers

Intervention

Drug:
• Androxal 25 mg Capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.		24 hour	No