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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Androxal 25 mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 70 years or older; Non-smoking healthy adult males >or equal to 70 years of age.	Drug: Androxal 25 mg
Experimental: Under 60 years of age; Non-smoking healthy adult males<60 years of age.	Drug: Androxal 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics - The Cmax will be calculated.	4 days
Pharmacokinetics - The Tmax will be calculated.	4 days
Pharmacokinetics - The AUC0-24 will be calculated.	4 days
Pharmacokinetics - the AUC0-∞ will be calculated.	4 days
Pharmacokinetics - The t½ will be calculated.	4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety - Incidence of adverse events	4 days
Safety -Mean change from baseline in laboratory values	4 days
Safety - Mean change from baseline in vital signs	4 days

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Enclomiphene
• Other Study ID Numbers: ZA-111