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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752843
• Other study ID #: C-1073-16
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2008
• Last updated: February 15, 2012
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: February 2012
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• mifepristone + 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).

Locations

Country	Name	City	State
United States	MDS Pharma	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Corcept Therapeutics
•   MDS Pharma