Trial · Interventional
CompletedPhase 1Registry dataA Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 54 participants (estimated)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
- Not stated
- Start
- Apr 2014
- Primary completion
- May 2014
- Completion
- Not stated
- First posted
- 21 Apr 2014 (estimated)
- Last update posted
- 16 Jun 2014 (estimated)
- Conditions
- Healthy
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
NCT02117830Apr 2014 to May 2014 (primary)
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and the positive control. In each Treatment Period subjects will be admitted to a Clinical Research Unit where study drug will be administered as three (3) daily single doses. Treatment Periods will be separated by a washout of at least 7 days between Periods.
Interventions
- Androxal 25 mg capsulesDrug
- Androxal 250 CapsulesDrug
- Placebo CapsulesDrug
- Moxifloxacin 400 mgDrug
Arms4
Experimental
Androxal 25 mg
Experimental
Androxal 250 mg
supratherapeutic dose
Placebo comparator
Placebo
Other
Moxifloxacin 400 mg
positive control
Primary outcomes1
Outcomes the sponsor listed as primary.
The placebo-subtracted change of the QTc interval from Baseline (ΔΔQTc) defined as: the change of QTc from the subject-specific and period-specific Baseline (ΔQTc), less the time-matched placebo value of change of QTc
Time frame · 64 days
Registry description
The placebo-subtracted change of the QTc interval from Baseline (ΔΔQTc) defined as: the change of QTc from the subject-specific and period-specific Baseline (ΔQTc), less the time-matched placebo value of change of QTc
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 up to 60 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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