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

Condition(s) targeted: Healthy Subjects

Intervention: mifepristone + fluvastatin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Corcept Therapeutics

Official(s) and/or principal investigator(s):
Dennis Swearingen, MD, Principal Investigator, Affiliation: MDS Pharma
Thaddeus Block, MD, Study Director, Affiliation: Corcept Therapeutics

Overall contact:
Thaddeus Block, MD, Phone: 650-327-3270, Email: tblock@corcept.com

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.

Official title: 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

Study design: Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: 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.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Thaddeus Block, MD, Phone: 650-327-3270, Email: tblock@corcept.com

MDS Pharma, Tempe, Arizona 85283, United States; Recruiting
Phone: 888-257-9393
Dennis Swearingen, MD, Principal Investigator

Corcept Therapeutics

MDS Pharma

Starting date: September 2008
Ending date: December 2008
Last updated: September 18, 2008