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

NCT00637403 | Terminated Phase 1

• 1 other identifier: 100.2.C.002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

renal impairment; end stage renal disease; megestrol acetate; pharmacokinetics; hemodialysis; renal dialysis; kidney failure, chronic; renal insufficiency; Megace ES

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic blood samples

  predose and serially through 264 hours post dose

• Urine collection

  Predose and serially through 264 hours post dose

Study Arms (5)

I

ACTIVE COMPARATOR

Megestrol acetate concentrated suspension in subjects with normal renal function

Drug: Megestrol acetate concentrated suspension 125 mg/mL

II

EXPERIMENTAL

Megestrol acetate concentrated suspension in subjects with mild renal impairment

Drug: Megestrol acetate concentrated suspension 125 mg/mL

III

EXPERIMENTAL

Megestrol acetate concentrated suspension in subjects with moderate renal impairment

Drug: Megestrol acetate concentrated suspension 125 mg/mL

IV

EXPERIMENTAL

Megestrol acetate concentrated suspension in subjects with severe renal impairment

Drug: Megestrol acetate concentrated suspension 125 mg/mL

V

EXPERIMENTAL

Megestrol acetate concentrated suspension in subjects with end stage renal disease

Drug: Megestrol acetate concentrated suspension 125 mg/mL

Interventions

Megestrol acetate concentrated suspension 125 mg/mL DRUG

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)

Also known as: Megace ES

I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Subjects with Normal Renal Function
• BMI ≥18 kg/m2 and ≤35 kg/m2
• 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
• Able to provide written informed consent
• Normal renal function, defined as estimated creatinine clearance (CLcr) \>80 mL/min at screening
• Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD
• 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)
• 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
• ESRD subjects require hemodialysis for at least 3 months
• 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
• Subjects with renal impairment or ESRD, must have stable underlying medical conditions for at least 90 days prior to the start of study participation
• Renal impaired subjects may smoke up to 5 cigarettes per day

You may not qualify if:

• Healthy Subjects with Normal Renal Function
• 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
• Presence of any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator
• 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
• 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
• History of allergic reaction or serum sickness to any drug or drug metabolites
• 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
• Positive test for HIV antibody or hepatitis B surface antigen (positive HIV or hepatitis C antibody for ESRD subjects are acceptable)
• Presence of drugs of abuse and/or alcohol
• Participation in another investigational drug study within 30 days prior to the first MA-CS dose
• History of recent drug abuse or alcohol addiction during past 2 years
• Pregnant or breastfeeding
• Consumption of grapefruit containing foods and beverages within 7 days prior to the first MA-CS dose
• 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

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Covance: collaborator
• SFBC Anapharm: collaborator

Study Sites (1)

SFBC International

Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kenneth C Lasseter, MD

  SFBC International

  PRINCIPAL INVESTIGATOR

• Lynn D. Kramer, MD

  Par Pharmaceutical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: May 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)