Secondary Hypogonadism
Conditions
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.
Interventions
DRUGAndroxal 25 mg
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects with Impaired Renal Function: Subjects with various stages of impaired renal function must meet all of the following inclusion criteria at screening will be considered for admission to the study: 1. 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; 2. Male, between the ages of 18 and 80 years with Body Mass Index (BMI) between 25 and 42, inclusive, are preferred. 3. 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) 4. Subjects must have evidence of stable renal impairment as determined by the Investigator (See Section 9.3.2, Day -1) 5. 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; 6. 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); 7. 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); 8. Must be able to swallow gelatin capsules; Subjects with Normal Renal Function: Healthy volunteers meeting all of the following inclusion criteria at screening will be considered for admission to the study: 1. 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; 2. Male, between the ages of 18 and 60 years with Body Mass Index (BMI) between 25 and 39, inclusive; 3. Creatinine clearance \> 80 mL/min; 4. 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; 5. No significant abnormal findings at the screening physical examination as evaluated by the Investigator; 6. Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator; 7. Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days); 8. No tobacco (nicotine products) use for at least three (3) months prior to the study; 9. Must be able to swallow gelatin capsules
Exclusion criteria
Subjects with Impaired Renal Function Subjects with various stages of impaired renal function meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | 24 hours | Pharmacokinetic parameters calculated as a ratio in subjects with mild or moderate renal impairment to normal after a single dose of 25 mg Androxal. |
Countries
United States
Outcome results
None listed