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mifepristone + fluvastatin

Phase 1

Healthy Subjects | Small molecule | Other |Corcept Therapeutics Incorporated|Last Updated: Feb 17, 2012

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical trial landscape

mifepristone + fluvastatin · 1 trial · 1 indication

Phase 1 1
NCT00752843A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy VolunteersHealthy Subjects
COMPLETED20 Analytics
PHASE1COMPLETED
A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers
Healthy Subjects
NCT0075284320
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Study Endpoints
Primary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
mifepristone + fluvastatinDRUGSubjects 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).
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ch...

Countries:United States
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