A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Androxal 25 mg capsules
* Drug: Androxal 250 Capsules
* Drug: Placebo Capsules
* Drug: Moxifloxacin 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy males as determined by history and physical examination Between the ages of 18 and 60, inclusive Clinical laboratory test results within the normal reference ranges for the investigative site or results with acceptable deviations that are judged by the principal investigator to be not clinically significant Vital signs (after 5 minutes resting in a supine position) Systolic blood pressure (SBP) 90-140 mmHg, and Diastolic blood pressure (DBP) 50-90 mmHg, and Pulse 45-100 bpm Note: subjects with vital signs outside the above ranges may be eligible for the study if the Investigator feels that the results are not clinically significant and will not impact study conduct. Body mass index (BMI) ≥25 to ≤42 kg/m2 at Screening Are reliable and willing to be available for the duration of the study, abiding by the policies and procedures of the clinical trials unit Have given written informed consent Subject must be able to speak, read and understand English or Spanish and be willing and able to provide written informed consent in English or Spanish on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written informed consent form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications. Exclusion Criteria: Repros employee or investigative site personnel and their immediate families Participation in a clinical trial within the past 30 days or receipt of any investigational agent or study treatment within 30 days or 5 half-lives, whichever is longer, prior to Screening Known hypersensitivity to Clomid Known allergy to moxifloxacin 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: an abnormality of cardiac rhythm other than sinus arrhythmia QTcF > 450 msec QTcF < 300 msec PR interval >200 msec QRS > 110 msec abnormal T wave morphology that will impair the ability to measure the QT interval reliably History of congenital long QT syndrome or known history of QTc interval prolongation or family history of congenital long QT syndrome Evidence of significant cardiac disease, for example, arrhythmia or unexplained syncope within the last year History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, History of thrombophlebitis, thromboembolic disorder or cerebrovascular accident Evidence of significant respiratory or hepatic disease Use of cigarettes or any tobacco product within 2 weeks prior to Screening and while participating in the study Use of any medications other than acetaminophen or aspirin (prescription or over-the-counter), herbal tea , energy drinks, supplements, within 5 days of dosing (prior to first dose of study medications), with the exception of those approved by the Investigator and Sponsor Use of drugs of abuse and/or positive findings on drug screen Known active infection with HIV or hepatitis B or C.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androxal 25 mg<br> | Drug: Androxal 25 mg capsules<br> <br> |
| Experimental: Androxal 250 mg<br>supratherapeutic dose | Drug: Androxal 250 Capsules<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo Capsules<br> <br> |
| Other: Moxifloxacin 400 mg<br>positive control | Drug: Moxifloxacin 400 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 64 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To determine, effects, once, daily, oral doses, Androxal