Healthy Subjects
Conditions
Keywords
mifepristone, CORLUX, fluvastatin, Lescol, drug-drug interaction, DDI, pharmacokinetics
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.
Interventions
DRUGmifepristone + fluvastatin
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).
Sponsors
Corcept Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed