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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169804
• Other study ID #: ZA-111
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2014
• Last updated: September 29, 2014
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: September 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

• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

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 <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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Androxal 25 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - The Cmax will be calculated.		4 days	Yes
Primary	Pharmacokinetics - The Tmax will be calculated.		4 days	Yes
Primary	Pharmacokinetics - The AUC0-24 will be calculated.		4 days	Yes
Primary	Pharmacokinetics - the AUC0-8 will be calculated.		4 days	Yes
Primary	Pharmacokinetics - The t½ will be calculated.		4 days	Yes
Secondary	Safety - Incidence of adverse events		4 days	Yes
Secondary	Safety -Mean change from baseline in laboratory values		4 days	Yes
Secondary	Safety - Mean change from baseline in vital signs		4 days	Yes