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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2014
Primary completion
Aug 2014
Completion
Aug 2014
First posted
23 Jun 2014 (estimated)
Last update posted
1 Oct 2014 (estimated)
Conditions
Pharmacokinetics

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

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

    NCT02169804

    Aug 2014 to Aug 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Androxal 25 mgDrug

Arms2

  • Experimental

    70 years or older

    Non-smoking healthy adult males \>or equal to 70 years of age.

  • Experimental

    Under 60 years of age

    Non-smoking healthy adult males\<60 years of age.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics - The Cmax will be calculated.

    Time frame · 4 days

  2. Pharmacokinetics - The Tmax will be calculated.

    Time frame · 4 days

  3. Pharmacokinetics - The AUC0-24 will be calculated.

    Time frame · 4 days

  4. Pharmacokinetics - the AUC0-∞ will be calculated.

    Time frame · 4 days

  5. Pharmacokinetics - The t½ will be calculated.

    Time frame · 4 days

Secondary outcomes(3)
  1. Safety - Incidence of adverse events

    Time frame · 4 days

  2. Safety -Mean change from baseline in laboratory values

    Time frame · 4 days

  3. Safety - Mean change from baseline in vital signs

    Time frame · 4 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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