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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Fluvastatin; Mifepristone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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