Clinical trial NCT00752843: A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: mifepristone
CORLUX
fluvastatin
Lescol
drug-drug interaction
DDI
pharmacokinetics
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 8, 9, 12, 13, 14, & 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: MDS Pharma
state: Arizona
Study officials:
affiliation: MDS Pharma
name: Dennis Swearingen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corcept Therapeutics
name: Thaddeus Block, MD
role: STUDY_DIRECTOR
References: