A Phase 1 interventional study of Androxal 25 mg capsules and Androxal 250 Capsules in Healthy, sponsored by Repros Therapeutics Inc.. Completed. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-16.
Sponsored by Repros Therapeutics Inc. · Phase 1 and Interventional
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.
Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Vital signs (after 5 minutes resting in a supine position)
Exclusion Criteria:
Abnormal electrocardiogram that, after the option of repeating any such findings, in the opinion of the Investigator and/or Sponsor may interfere with any aspect of study conduct or interpretation of results including:
Drug: Androxal 25 mg capsules
supratherapeutic dose
Drug: Androxal 250 Capsules
Drug: Placebo Capsules
positive control
Drug: Moxifloxacin 400 mg
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
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
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Repros Therapeutics Inc.