A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers

NCT00752843 | Completed Phase 1 DMC

• 1 other identifier: C-1073-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the effect of single and multiple oral doses of mifepristone on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.

Conditions

Healthy Subjects

Keywords

mifepristone; CORLUX; fluvastatin; Lescol; drug-drug interaction; DDI; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To determine the effect of single and multiple oral doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.

  8, 9, 12, 13, 14, & 15 days

Study Arms (1)

1

EXPERIMENTAL

Drug: mifepristone + fluvastatin

Interventions

mifepristone + fluvastatin DRUG

Subjects will receive a single oral dose of 40 mg PO of fluvastatin on three occasions: alone (Day 1), at the same time as a single dose of CORLUX 1200 mg (Day 8) and during concomitant administration of CORLUX 1200 mg/day (CORLUX on Days 8-14, fluvastatin on Day 14).

Also known as: CORLUX + Lescol

1

Eligibility Criteria

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

You may qualify if:

• Male or female healthy volunteers
• Body mass index (BMI) of 18-32 kg/m2
• Female subjects must have a negative serum pregnancy test result prior to entry into the study
• All female subjects must not be of child-bearing potential
• All male subjects with female partners of childbearing potential must consent to use a medically acceptable double-barrier method of contraception and not donate sperm throughout the study period and for at least 3 months (90 days) after the last dose of study medication
• The subject agrees to abstain from grapefruit or grapefruit juice for at least 2 weeks prior to the first dose and until completion of the pharmacokinetic sampling (Day 15)
• The subject must be able to provide written informed consent

You may not qualify if:

• Any acute or chronic disease state, including but not limited to cardiovascular, dermatological, endocrine, gastrointestinal, hepatic, pulmonary, and renal conditions determined to be clinically significant by the Investigator
• Any clinically significant abnormal clinical laboratory tests as determined by the Investigator
• Any concomitant medications (including prescription, over-the-counter or illicit) within either 30 days or five half-lives (whichever is shorter) prior to dosing
• Positive urine drug screen for any illicit drugs
• Use of tobacco or any nicotine-containing products during the previous three months
• Grapefruit juice within two weeks prior to first dose
• Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
• Signs and/or symptoms such as orthostatic hypotension, fatigue, anorexia, nausea, abdominal pain, joint and muscle pain if considered to be a marker of adrenal insufficiency
• History of an allergic reaction to mifepristone or fluvastatin
• Positive serum test for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus
• Blood donation within 30 days of dosing

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

MDS Pharma

Tempe, Arizona, 85283, United States

Location

Related Links

• Corcept Therapeutics
• MDS Pharma

MeSH Terms

Interventions

Mifepristone; Fluvastatin; Corlux

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Dennis Swearingen, MD

  MDS Pharma

  PRINCIPAL INVESTIGATOR

• Thaddeus Block, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)