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

NCT00637403 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-10-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • SFBC Anapharm

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth C Lasseter, MD · SFBC International

  • Lynn D. Kramer, MD · Par Pharmaceutical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637403 on ClinicalTrials.gov