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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androxal 25 mg | Experimental |
| |
| Androxal 250 mg | Experimental | supratherapeutic dose |
|
| Placebo | Placebo Comparator |
| |
| Moxifloxacin 400 mg | Other | positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal 25 mg capsules | Drug |
| ||
| Androxal 250 Capsules |
| 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 |
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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)
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:
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.
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| ID | Term |
|---|---|
| D064695 | Enclomiphene |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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|
| Placebo Capsules | Drug |
|
| Moxifloxacin 400 mg | Drug |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |