Trial · Interventional
CompletedPhase 1Registry dataAn 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
- Ph 1
An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
NCT02169804Aug 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.
Pharmacokinetics - The Cmax will be calculated.
Time frame · 4 days
Pharmacokinetics - The Tmax will be calculated.
Time frame · 4 days
Pharmacokinetics - The AUC0-24 will be calculated.
Time frame · 4 days
Pharmacokinetics - the AUC0-∞ will be calculated.
Time frame · 4 days
Pharmacokinetics - The t½ will be calculated.
Time frame · 4 days
Secondary outcomes(3)
Safety - Incidence of adverse events
Time frame · 4 days
Safety -Mean change from baseline in laboratory values
Time frame · 4 days
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
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