Normal VolunteersPhase 1NCT02146391
Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal
A Phase 1 study testing Androxal 25 mg Capsules in people with Normal Volunteers, run by Repros Therapeutics Inc..
Trial summary
This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state. 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
- Normal Volunteers
- What is being tested?
- Androxal 25 mg Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 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
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive
- 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 for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit)
- Must be able to swallow gelatin capsules;
- Must be willing to remain in the clinic for the treatment visits
Who cannot join
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- A hematocrit >54% or a hemoglobin >17 g/dL.
- 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;
- Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
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- An acute illness within 5 days of study medication administration;
- Positive urine drug screen at the screening visit;
- Known history of HIV and/or Hepatitis B or C
- Tobacco (nicotine products) use in the 3 months prior to the study;
- 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;
- Previous participation in a clinical study of Androxal.
About this study
Official title: AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL
This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.
- Conditions
- Normal Volunteers
- Being tested
- Androxal 25 mg Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal 25 mg CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Androxal 25 mg | Experimental | Not described Receives: Drug: Androxal 25 mg Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VolunteersStudies 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146391
- Sponsor's protocol ID
- ZA-107
- Status last verified
- Aug 2014
- First submitted
- 21 May 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- 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
- AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL
- ClinicalTrials.gov ID
- NCT02146391
- Acronym / sponsor ID
- ZA-107
- Conditions
- Normal Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 May 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 study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Androxal 25 mg | Experimental | Drug: Androxal 25 mg Capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive
- 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 for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit)
Key exclusion criteria (15 listed)
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- A hematocrit >54% or a hemoglobin >17 g/dL.
- 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;
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 |
Primary outcome
• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
Time frame: 24 hour
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 11 Aug 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 in people with Normal Volunteers, 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 7 inclusion and 15 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.
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?
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?
• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state. (time frame: 24 hour). 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.