PharmacokineticsPhase 1NCT01959685
A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
A Phase 1 study testing Androxal in people with Pharmacokinetics and Tolerability, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study. 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
- Pharmacokinetics, Tolerability
- What is being tested?
- Androxal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Male, between the ages of 18-60 years;
- No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
- Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
- Subject is willing to remain in the clinic overnight for the Day 1 and Day 8 visits;
- Must be able to swallow gelatin capsules
Who cannot join
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- Subject with a significant organ abnormality or disease as determined by the Investigator;
- Any medical condition that would interfere with the study as determined by the Investigator;
- Slow cytochrome P450 2D6 (CYP2D6) metabolizer
- Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
Show all 12Show fewer
- An acute illness within 5 days of study medication administration;
- Positive urine drug screen at the screening visit;
- A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
- History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
- An employee or family member of an employee of the study site or the Sponsor;
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Miami, Florida, 33014
About this study
Official title: A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
Read the detailed description
A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
- Conditions
- Pharmacokinetics, Tolerability
- Being tested
- Androxal, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroxalDrug
Also called Enclomiphene citrate
125 mg Androxal, 250 mg Androxal separated by at least 7 days
PlaceboDrug
Also called Sugar pill
Placebo, single dose
| Study group | Role | What they receive |
|---|---|---|
| Dose escalting | Experimental | Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose Receives: Drug: Androxal; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Cmax of a single dose 125 mg of Androxal
Measured: 24 hrs
Cmax of a Single Dose of 250 mg Androxal
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph S Podolski, Study chair, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959685
- Sponsor's protocol ID
- ZA-109
- Status last verified
- Jul 2014
- First submitted
- 8 Oct 2013
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01959685
- Acronym / sponsor ID
- ZA-109
- Conditions
- Pharmacokinetics, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
Detailed description
A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalting | Experimental | Drug: Androxal, Drug: PlaceboPlacebo, 125 mg Androxal, 250 mg Androxal each given as a single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Male, between the ages of 18-60 years;
- No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
- Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
- Subject is willing to remain in the clinic overnight for the Day 1 and Day 8 visits;
Key exclusion criteria (12 listed)
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- Subject with a significant organ abnormality or disease as determined by the Investigator;
- Any medical condition that would interfere with the study as determined by the Investigator;
- Slow cytochrome P450 2D6 (CYP2D6) metabolizer
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 |
|---|---|---|
| AndroxalAlso: Enclomiphene citrate125 mg Androxal, 250 mg Androxal separated by at least 7 days | Drug | Dose escalting |
| PlaceboAlso: Sugar pillPlacebo, single dose | Drug | Dose escalting |
Primary outcome
Pharmacokinetics
Time frame: 24 hrs
Cmax of a single dose 125 mg of Androxal
Cmax of a Single Dose of 250 mg Androxal
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor corporate web siteLink provided by the sponsor.
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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.
Joseph S Podolski study chair
Repros Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Androxal in people with Pharmacokinetics and Tolerability, run by Repros Therapeutics Inc. at 1 site in United States.
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 6 inclusion and 12 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 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetics (time frame: 24 hrs). The study lists 2 primary outcomes in all. 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 11 Aug 2014.