A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers
NCT00752843 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2012-02-17
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.
Conditions
- Healthy Subjects
Interventions
- 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).
Sponsors & Collaborators
-
Corcept Therapeutics
lead INDUSTRY
Principal Investigators
-
Dennis Swearingen, MD · MDS Pharma
-
Thaddeus Block, MD · Corcept Therapeutics
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- United States
Study Locations
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