Normal Volunteers
Conditions
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.
Interventions
Sponsors
Repros Therapeutics Inc.
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state. | 24 hour |
Outcome results
None listed