MD Ezetimibe Cyclosporine Interaction (0653-057)

Cholesterol Clinical Trial

Official title:

An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653276
• Other study ID #: 0653-057
• Secondary ID: MK0653-0572008_5
• Status: Completed
• Phase: Phase 1
• Start date: November 2003
• Est. completion date: January 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subject is male or female between 18 to 45 years of age

• Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data

Exclusion Criteria:

• Premenopausal women who are currently pregnant or who are currently nursing

• Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol

• Subject that has donated blood or has participated in another clinical trial within the last four weeks

Related Conditions & MeSH terms

• Cholesterol

Intervention

Drug:
• ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
• Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Schering-Plough

References & Publications (1)

Bergman AJ, Burke J, Larson P, Johnson-Levonas AO, Reyderman L, Statkevich P, Kosoglou T, Greenberg HE, Kraft WK, Frick G, Murphy G, Gottesdiener K, Paolini JF. Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects. J Clin Pharmacol. 2006 Mar;46(3):321-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone.		Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.