Secondary HypogonadismPhase 1NCT01923870
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
A Phase 1 study testing Androxal 25 mg in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Androxal 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Normal Hepatic Function:
- Speak, read, and understand 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 and 70 years with Body Mass Index (BMI) between 25 and 42, inclusive;
- Subjects in the control group, generally matched for age and BMI to patients enrolled in the test group: should be ± 15 years of the mean of the population with impaired hepatic function included in the study and ± 15% of the average BMI of subjects with impaired hepatic function;
- Subjects with creatinine clearance >80 mL/min;
- No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
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- Normal laboratory values at screening as determined by the Investigator;
- Subject is willing to remain in the clinic for the screening visit and for two treatment visits (approximately 3 days for each treatment visit);
- No tobacco (nicotine products) use for at least 3 months prior to the study;
- Must be able to swallow gelatin capsules;
- Subjects with Moderately Impaired Hepatic Function:
- Subjects with moderately impaired hepatic function must meet the criteria for normal hepatic function subjects specified above with the following exceptions:
- Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria. Hepatic impairment will be determined by the Investigator. Substantiation for the diagnosis must be indicated in source documents;
- Subjects must have evidence of stable hepatic impairment as determined by the Investigator. Stability is defined as no change in Class determination (A,B,C) based on the Child-Pugh criteria assessed during the screening visit and prior to the first dosing;
- If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study. The medications must be recorded in source documents.
- Non-smokers are preferred, but as this is a very restricted population light to moderate smoking will be allowed (no more than 10 cigarettes/day).
- Subjects between the age of 18 and 48 years are preferred; however, up to 70 years old of subjects may participate.
Who cannot join
- Subjects with Normal Hepatic Function
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- Physical examination finding of ascites;
- Subjects with abnormal liver function;
- A history of/or physical examination finding of abdominal or peripheral varicosities;
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- Subject with a significant organ abnormality or disease as determined by the Investigator;
- A physical illness within 1 year of the study 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;
- An acute illness within 5 days of study medication administration;
- Positive urine drug or infectious disease 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 corrected QT (QTc) interval prolongation;
- The use of prohibited concomitant medications: drugs that interfere with cytochrome P450 2D6 (CYP2D6) activity must cease for seven (7) days prior to first dose of study drug;
- An employee or family member of an employee of the study site or the Sponsor;
- Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled into the study.
- Subjects with Moderately Impaired Hepatic Function
- Subjects with moderately impaired hepatic function must meet the criteria for normal hepatic function subjects specified above with the following exceptions:
- Subjects with diseases that may cause hepatic impairment as determined by the Investigator;
- Subjects with a clinical, physical and laboratory findings that are related to hepatic impairment as determined by the Investigator;
- Subjects with medications necessary to manage hepatic impairment as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Hepatic Function
- To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal 25 mg
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal 25 mgDrug
Also called enclomiphene citrate
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Males age 18-70 with a BMI between 25-42 kg/m^2 with moderate hepatic impairment (Child-Pugh Class B) Receives: Drug: Androxal 25 mg |
| Healthy Volunteers | Experimental | Males age 18-70 with a BMI between 25-42 kg/m^2 Receives: Drug: Androxal 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Pharmacokinetic parameters calculated as a ratio of hepatically impaired to normal of a single dose of 25 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 posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HypogonadismStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT01923870
- Sponsor's protocol ID
- ZA-105
- Status last verified
- Jan 2014
- First submitted
- 13 Aug 2013
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT01923870
- Acronym / sponsor ID
- ZA-105
- Conditions
- Secondary Hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Aug 2013 (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.
- To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: Androxal 25 mgMales age 18-70 with a BMI between 25-42 kg/m^2 with moderate hepatic impairment (Child-Pugh Class B) |
| Healthy Volunteers | Experimental | Drug: Androxal 25 mgMales age 18-70 with a BMI between 25-42 kg/m^2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Speak, read, and understand 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 and 70 years with Body Mass Index (BMI) between 25 and 42, inclusive;
- Subjects in the control group, generally matched for age and BMI to patients enrolled in the test group: should be ± 15 years of the mean of the population with impaired hepatic function included in the study and ± 15% of the average BMI of subjects with impaired hepatic function;
- Subjects with creatinine clearance >80 mL/min;
- No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
Key exclusion criteria (22 listed)
- Subjects with Normal Hepatic Function
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- Physical examination finding of ascites;
- Subjects with abnormal liver function;
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 mgAlso: enclomiphene citrate | Drug | Healthy Volunteers, Moderate Hepatic Impairment |
Primary outcome
Pharmacokinetic parameters
Time frame: 24 hours
Pharmacokinetic parameters calculated as a ratio of hepatically impaired to normal of a single dose of 25 mg Androxal.
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 24 Jan 2014.
- Sponsor 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.
The record lists no contact. Use the official record to reach the sponsor.
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 25 mg in people with Secondary Hypogonadism, 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 17 inclusion and 22 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 24 Jan 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?
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?
Pharmacokinetic parameters (time frame: 24 hours). 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 24 Jan 2014.