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

Sponsor:	Corcept Therapeutics
Information provided by:	Corcept Therapeutics
ClinicalTrials.gov Identifier:	NCT00752843

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: mifepristone + fluvastatin	Phase I

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

Resource links provided by NLM:

Drug Information available for: Mifepristone Fluvastatin

U.S. FDA Resources

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:

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. [ Time Frame: 8, 9, 12, 13, 14, & 15 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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). Other Name: CORLUX + Lescol

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752843

Locations

United States, Arizona
MDS Pharma
Tempe, Arizona, United States, 85283

Sponsors and Collaborators

Corcept Therapeutics

Investigators

Principal Investigator:	Dennis Swearingen, MD	MDS Pharma
Study Director:	Thaddeus Block, MD	Corcept Therapeutics

More Information

Additional Information:

Corcept Therapeutics This link exits the ClinicalTrials.gov site

MDS Pharma This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Thaddeus Block, MD, Corcept Therapeutics
ClinicalTrials.gov Identifier:	NCT00752843 History of Changes
Other Study ID Numbers:	C-1073-16
Study First Received:	September 12, 2008
Last Updated:	November 12, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:

mifepristone
CORLUX
fluvastatin
Lescol

drug-drug interaction
DDI
pharmacokinetics

Additional relevant MeSH terms:

Mifepristone
Fluvastatin
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012