Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05218980 - Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Withdrawn NCT03729141 - Dietary Cholesterol and Adipose Tissue Inflammation N/A
Completed NCT04114916 - Clinical Trial to Evaluate the Reduction of Cardiovascular Risk N/A
Recruiting NCT04546126 - Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4) Early Phase 1
Completed NCT05267301 - AlmegaPL CV Health Open Label Study Phase 4
Completed NCT02259153 - Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis N/A
Completed NCT02169245 - Effects of Protein and Fiber at Breakfast on Appetite, Blood Sugar, and Cholesterol N/A
Recruiting NCT01890889 - Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health N/A
Completed NCT00652301 - A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED) Phase 3
Completed NCT01239914 - CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)
Recruiting NCT04532489 - Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1) Early Phase 1
Completed NCT03985917 - Singing Groups for Seniors: Well-Being, Cognitive Function and Health N/A
Completed NCT01494298 - Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes N/A