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Trial · Interventional

CompletedPhase 1Registry data

A 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
20142015
  1. Ph 1

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

    NCT02117830

    Apr 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.

  1. 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
Inclusion Criteria: 1. Generally healthy males as determined by history and physical examination 2. Between the ages of 18 and 60, inclusive 3. 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 4. 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. 5. Body mass index (BMI) ≥25 to ≤42 kg/m2 at Screening 6. Are reliable and willing to be available for the duration of the study, abiding by the policies and procedures of the clinical trials unit 7. Have given written informed consent 8. 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: 1. Repros employee or investigative site personnel and their immediate families 2. 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 3. Known hypersensitivity to Clomid 4. Known allergy to moxifloxacin 5. 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 6. History of congenital long QT syndrome or known history of QTc interval prolongation or family history of congenital long QT syndrome 7. Evidence of significant cardiac disease, for example, arrhythmia or unexplained syncope within the last year 8. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, 9. History of thrombophlebitis, thromboembolic disorder or cerebrovascular accident 10. Evidence of significant respiratory or hepatic disease 11. Use of cigarettes or any tobacco product within 2 weeks prior to Screening and while participating in the study 12. 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 13. Use of drugs of abuse and/or positive findings on drug screen 14. Known active infection with HIV or hepatitis B or C.

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