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

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: mifepristone + fluvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00752843

C-1073-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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