![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Covance SFBC Anapharm |
---|---|
Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00637403 |
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
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Megestrol acetate concentrated suspension 125 mg/mL |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Single-Dose Study to Assess the Effect of Renal Impairment on the Pharmacokinetic Characteristics, Safety, and Tolerability of Megestrol Acetate |
Enrollment: | 7 |
Study Start Date: | May 2006 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Active Comparator
Megestrol acetate concentrated suspension in subjects with normal renal function
|
Drug: Megestrol 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)
|
II: Experimental
Megestrol acetate concentrated suspension in subjects with mild renal impairment
|
Drug: Megestrol 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 mild renal impairment (CLcr 50 - 80 mL/min)
|
III: Experimental
Megestrol acetate concentrated suspension in subjects with moderate renal impairment
|
Drug: Megestrol 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 moderate renal impairment (CLcr 30 - <50 mL/min)
|
IV: Experimental
Megestrol acetate concentrated suspension in subjects with severe renal impairment
|
Drug: Megestrol 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 severe renal impairment (CLcr <30 mL/min and not on hemodialysis)
|
V: Experimental
Megestrol acetate concentrated suspension in subjects with end stage renal disease
|
Drug: Megestrol acetate concentrated suspension 125 mg/mL
Megestrol acetate concentrated suspension (125 mg/mL) administered orally as 2 single doses of 300 mg (2.4 mL x 125 mg/mL) each in subjects with end stage renal disease undergoing hemodialysis. Washout period of 21 days between each dose
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy Subjects with Normal Renal Function
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
Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD
Meet inclusion criteria 1 through 3 for healthy subjects and the following criteria:
Exclusion Criteria:
Healthy Subjects with Normal Renal Function
Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD
Excluded if subjects meet exclusion criteria 4 through 13 for healthy subjects and the following criteria:
United States, Florida | |
SFBC International | |
Miami, Florida, United States, 33181 |
Principal Investigator: | Kenneth C Lasseter, MD | SFBC International |
Study Director: | Lynn D. Kramer, MD | Par Pharmaceutical, Inc. |
Responsible Party: | Par Pharmaceutical, Inc ( VP Clinical & Medical Affairs ) |
Study ID Numbers: | 100.2.C.002 |
Study First Received: | March 11, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00637403 History of Changes |
Health Authority: | United States: Food and Drug Administration |
renal impairment end stage renal disease megestrol acetate pharmacokinetics hemodialysis |
renal dialysis kidney failure, chronic renal insufficiency Megace ES |
Renal Insufficiency Antineoplastic Agents, Hormonal Contraceptive Agents Contraceptives, Oral Kidney Failure, Chronic Contraceptive Agents, Female Central Nervous System Stimulants |
Healthy Megestrol Kidney Diseases Megestrol Acetate Appetite Stimulants Kidney Failure |
Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants Reproductive Control Agents |
Megestrol Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Megestrol Acetate Appetite Stimulants |