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CompletedNCT02117830Updated Jun 16, 2014

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • To determine
  • effects
  • once
  • daily
  • oral doses
  • Androxal
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Androxal 25 mg

    Drug: Androxal 25 mg capsules

  • Experimental
    Androxal 250 mg

    supratherapeutic dose

    Drug: Androxal 250 Capsules

  • Placebo comparator
    Placebo

    Drug: Placebo Capsules

  • Other
    Moxifloxacin 400 mg

    positive control

    Drug: Moxifloxacin 400 mg

Interventions

  • DrugAndroxal 25 mg capsules
  • DrugAndroxal 250 Capsules
  • DrugPlacebo Capsules
  • DrugMoxifloxacin 400 mg
06

What researchers measure

Primary outcomes

  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

    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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02117830
Lead sponsor
Repros Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Apr 2014
Primary completion
May 2014
Last update
Jun 16, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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