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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I, Open-Label, Fixed-Sequence Study to Determine the Effect of Single and Multiple Oral Doses of CORLUX (TM) (Mifepristone) on the Pharmacokinetics of a Single Oral Dose of Fluvastatin (a CYP2C9 Probe) in Healthy Volunteers

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: mifepristone + fluvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mifepristone + fluvastatin<br>* 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).<br>* Other names: CORLUX + Lescol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mifepristone, CORLUX, fluvastatin, Lescol, drug-drug interaction, DDI, pharmacokinetics