- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01923870
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
January 23, 2014 updated by: Repros Therapeutics Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33014
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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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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;
- 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.
Exclusion Criteria:
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;
- 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.
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Moderate Hepatic Impairment
Males age 18-70 with a BMI between 25-42 kg/m^2 with moderate hepatic impairment (Child-Pugh Class B)
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Other Names:
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Experimental: Healthy Volunteers
Males age 18-70 with a BMI between 25-42 kg/m^2
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters
Time Frame: 24 hours
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Pharmacokinetic parameters calculated as a ratio of hepatically impaired to normal of a single dose of 25 mg Androxal.
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24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
August 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
August 14, 2013
First Posted (Estimate)
August 16, 2013
Study Record Updates
Last Update Posted (Estimate)
January 24, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Clomiphene
- Enclomiphene
- Zuclomiphene
Other Study ID Numbers
- ZA-105
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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