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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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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 SubjectsUnlock trial analytics

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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Frequently asked questions about mifepristone+ fluvastatin

What is Mifepristone used for?

Mifepristone is being developed by Corcept Therapeutics for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. It is a small molecule in Phase 3 clinical development for these endocrine and psychiatric conditions. The drug is investigational and has not been approved for these indications.

Who makes Mifepristone?

Corcept Therapeutics Incorporated (NASDAQ: CORT) is developing Mifepristone. The company is conducting clinical trials for the drug in indications including Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. Corcept Therapeutics is the developer of this investigational small molecule.

What phase is Mifepristone in?

Mifepristone is in Phase 3 clinical development for Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. The drug is investigational and has not been approved by regulatory authorities for these indications. Corcept Therapeutics is conducting the clinical development program.

What clinical trials has Mifepristone been in?

Mifepristone has completed five clinical trials. These include NCT00455442, a Phase 2 study in weight-gain prevention; NCT00698022, a Phase 1 study in healthy volunteers; NCT03258372 and NCT03259542, Phase 1 drug-drug interaction studies; and one additional completed trial. All trials are completed with no active studies ongoing.

How does Mifepristone work?

Mifepristone is a small molecule that acts as a glucocorticoid receptor antagonist. By blocking the glucocorticoid receptor, it is being studied for its effects in Cushing's Syndrome, Cushing's Disease, and Major Depressive Disorder. This mechanism is relevant to conditions involving cortisol dysregulation.

Is Mifepristone the same as Korlym?

Mifepristone is the active ingredient in Korlym, a medication approved for Cushing's syndrome. However, the data provided does not specify whether the Mifepristone in development by Corcept Therapeutics is the same product as Korlym. The drug is being studied in Phase 3 trials for related indications.