Healthy
Conditions
Keywords
renal impairment, end stage renal disease, megestrol acetate, pharmacokinetics, hemodialysis, renal dialysis, kidney failure, chronic, renal insufficiency, Megace ES
Brief summary
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment
Interventions
DRUGMegestrol acetate concentrated suspension 125 mg/mL
Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with normal renal function (CLcr \>80 mL/min)
Sponsors
Covance
SFBC Anapharm
Par Pharmaceutical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Subjects with Normal Renal Function 1. BMI ≥18 kg/m2 and ≤35 kg/m2 2. Females of child-bearing potential must use an adequate and reliable method of contraception. Postmenopausal females must be postmenopausal ≥1 year and have elevated serum FSH 3. Able to provide written informed consent 4. Normal renal function, defined as estimated creatinine clearance (CLcr) \>80 mL/min at screening Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD Meet inclusion criteria 1 through 3 for healthy subjects and the following criteria: 1. Renal impairment defined as creatinine clearance \<80 mL/min as determined using the Cockroft-Gault formula. Subjects grouped according to degree of renal dysfunction: mild (CLcr = \>50 and ≤80 mL/min), moderate (CLcr = \>30 and ≤50 mL/min), or severe (CLcr = ≤30 mL/min) 2. Renal Impairment subjects must have evidence of stable renal impairment. Defined as having CLcr values within 25% of each other from 2 separately measured serum creatinine clearances using the Cockroft-Gault formula 3. ESRD subjects require hemodialysis for at least 3 months 4. Subjects with renal impairment or ESRD may have clinical laboratory test result deviations that are judged by the Investigator to be consistent with the renal condition of the subject or of no additional clinical significance for this study 5. Subjects with renal impairment or ESRD, must have stable underlying medical conditions for at least 90 days prior to the start of study participation 6. Renal impaired subjects may smoke up to 5 cigarettes per day
Exclusion criteria
Healthy Subjects with Normal Renal Function 1. Clinically significant (history of or active) cardiac, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease that could put the subject at increased risk or could interfere with the objectives of the study 2. Presence of any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator 3. Use of a prescription drug within 14 days of study start, a non-prescription drug within 7 days of study start, or need of concomitant medication during the study 4. Use of any drugs or herbal products known to inhibit or induce liver enzymes involved in drug metabolism (CYP P450) within 30 days prior to 1st dose 5. History of allergic reaction or serum sickness to any drug or drug metabolites 6. Whole blood donation within 56 days prior to the first MA-CS dose or plasma donation within 7 days prior to the first MA-CS dose 7. Positive test for HIV antibody or hepatitis B surface antigen (positive HIV or hepatitis C antibody for ESRD subjects are acceptable) 8. Presence of drugs of abuse and/or alcohol 9. Participation in another investigational drug study within 30 days prior to the first MA-CS dose 10. History of recent drug abuse or alcohol addiction during past 2 years 11. Pregnant or breastfeeding 12. Consumption of grapefruit containing foods and beverages within 7 days prior to the first MA-CS dose 13. History of recurrent thromboembolic events, a thromboembolic event in past three months, or those still receiving long-term anticoagulation for thromboembolism Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD Excluded if subjects meet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic blood samples | predose and serially through 264 hours post dose |
| Urine collection | Predose and serially through 264 hours post dose |
Countries
United States
Outcome results
None listed