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

June 13, 2014 updated by: Repros Therapeutics Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo Capsules
Experimental: Androxal 25 mg
Drug: Androxal 25 mg capsules
Experimental: Androxal 250 mg
supratherapeutic dose
Drug: Androxal 250 Capsules
Other: Moxifloxacin 400 mg
positive control
Drug: Moxifloxacin 400 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 64 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZA-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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