NCT00637403

Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension

An Open-Label, Single-Dose Study to Assess the Effect of Renal Impairment on the Pharmacokinetic Characteristics, Safety, and Tolerability of Megestrol Acetate

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
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)
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)
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)
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)
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

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2008-03-18
• Last updated: 2016-10-17

Locations

1 site across 1 country: United States