Clinical trial NCT02169804: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
Official title: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 \<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.

Primary outcomes:
measure: Pharmacokinetics - The Cmax will be calculated.
timeFrame: 4 days
measure: Pharmacokinetics - The Tmax will be calculated.
timeFrame: 4 days
measure: Pharmacokinetics - The AUC0-24 will be calculated.
timeFrame: 4 days
measure: Pharmacokinetics - the AUC0-∞ will be calculated.
timeFrame: 4 days
measure: Pharmacokinetics - The t½ will be calculated.
timeFrame: 4 days
Secondary outcomes:
measure: Safety - Incidence of adverse events
timeFrame: 4 days
measure: Safety -Mean change from baseline in laboratory values
timeFrame: 4 days
measure: Safety - Mean change from baseline in vital signs
timeFrame: 4 days
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
References: