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

This is a fixed-sequence, drug-drug interaction study in healthy volunteers lasting up to a total of 9 weeks: up to 4 weeks screening, approximately 2 weeks for dosing (including a 1-week washout between periods), and approximately 3 weeks of a drug-free interval until termination. The purpose of this study is 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.

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