Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

NCT01923857 | Completed Phase 1

• 1 other identifier: ZA-104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

• To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
• To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.

Conditions

Secondary Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  Pharmacokinetic parameters calculated as a ratio in subjects with mild or moderate renal impairment to normal after a single dose of 25 mg Androxal.

  24 hours

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL

Healthy males age 18-80 with a body mass index(BMI) 25-42 mg/m\^2.

Drug: Androxal 25 mg

Mild Renal Impairment

EXPERIMENTAL

Males with mild renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m\^2 (creatinine clearance 50-80 mL/min).

Drug: Androxal 25 mg

Moderate Renal Impairment

EXPERIMENTAL

Males with moderate renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m\^2 (creatinine clearance 30-50 mL/min).

Drug: Androxal 25 mg

Severe renal impairment

EXPERIMENTAL

Drug: Androxal 25 mg

Interventions

Androxal 25 mg DRUG

Also known as: enclomiphene citrate

Healthy Volunteers; Mild Renal Impairment; Moderate Renal Impairment; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with Impaired Renal 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 80 years with Body Mass Index (BMI) between 25 and 42, inclusive, are preferred.
• Subjects must meet the criteria of mildly (creatinine clearance 50-80 mL/min) or moderately (creatinine clearance 30-50 mL/min) impaired renal function. The Investigator will assess the renal impairment category of each subject. Substantiation for the diagnosis must be indicated in source documents; (See Appendix B)
• Subjects must have evidence of stable renal impairment as determined by the Investigator (See Section 9.3.2, Day -1)
• If on medications for treatment of the complications of renal 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 Androxal 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;
• Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the screening visit) and for the treatment visit (approximately 3 days);
• 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);
• Must be able to swallow gelatin capsules;
• Subjects with Normal Renal Function:
• 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, between the ages of 18 and 60 years with Body Mass Index (BMI) between 25 and 39, inclusive;
• Creatinine clearance \> 80 mL/min;
• Subjects in the control group, generally matched for age and BMI to patients enrolled in the test groups: should be ± 20 years of the mean of mildly and moderately renally impaired subjects included in the study and ± 20% of the average BMI of mildly and moderately renally impaired subjects;
• No significant abnormal findings at the screening physical examination as evaluated by the Investigator;

You may not qualify if:

• Subjects with Impaired Renal Function
• Known hypersensitivity to Clomid;
• Subjects with clinically significant abnormal liver function as determined by the Investigator;
• Subjects who are treated with dialysis;
• A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
• Participation in a clinical trial with investigational medication within four (4) weeks prior to study medication administration;
• A hematocrit \>54% or a hemoglobin \>17 g/dL. (Sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with high elevation).
• An acute illness within five (5) days of study medication administration;
• 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.
• Positive urine drug or infectious disease screen at the screening visit based on laboratory testing;
• 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 interval (QTc) interval prolongation;
• The use of prohibited concomitant medications:
• Drugs that may interfere with cytochrome P450 2D6 (CYP2D6) activity must cease for 7 days prior to first dose of study drug;

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (2)

Unknown Facility

Miami, Florida, 33014, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• Sponsor Web Site

MeSH Terms

Conditions

Hypogonadism

Interventions

Enclomiphene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (2)