HealthyPhase 1NCT02117830
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
A Phase 1 study testing Androxal 25 mg capsules, Androxal 250 Capsules and Moxifloxacin 400 mg in people with Healthy, run by Repros Therapeutics Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Androxal 25 mg capsules, Androxal 250 Capsules and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
About this study
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.
- Conditions
- Healthy
- Being tested
- Androxal 25 mg capsules, Androxal 250 Capsules, Placebo Capsules, Moxifloxacin 400 mg
- Keywords
- To determine, effects, once, daily, oral doses, Androxal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal 25 mg capsulesDrug
Androxal 250 CapsulesDrug
Placebo CapsulesDrug
Moxifloxacin 400 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Androxal 25 mg | Experimental | Not described Receives: Drug: Androxal 25 mg capsules |
| Androxal 250 mg | Experimental | supratherapeutic dose Receives: Drug: Androxal 250 Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Capsules |
| Moxifloxacin 400 mg | Other | positive control Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117830
- Sponsor's protocol ID
- ZA-108
- Status last verified
- Jun 2014
- First submitted
- 16 Apr 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02117830
- Acronym / sponsor ID
- ZA-108
- Conditions
- Healthy
- Keywords
- To determine, effects, once, daily, oral doses, Androxal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Androxal 25 mg | Experimental | Drug: Androxal 25 mg capsules |
| Androxal 250 mg | Experimental | Drug: Androxal 250 Capsulessupratherapeutic dose |
| Placebo | Placebo comparator | Drug: Placebo Capsules |
| Moxifloxacin 400 mg | Other | Drug: Moxifloxacin 400 mgpositive control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androxal 25 mg capsules | Drug | Androxal 25 mg |
| Androxal 250 Capsules | Drug | Androxal 250 mg |
| Placebo Capsules | Drug | Placebo |
| Moxifloxacin 400 mg | Drug | Moxifloxacin 400 mg |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Androxal 25 mg capsules, Androxal 250 Capsules and Moxifloxacin 400 mg in people with Healthy, run by Repros Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.