NCT00621101

Brief Summary

The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on each others pharmacokinetics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

February 22, 2008

Status Verified

February 1, 2008

Enrollment Period

2 months

First QC Date

February 12, 2008

Last Update Submit

February 12, 2008

Conditions

PharmacokineticsDrug InteractionsHypercholesterolemiaImmunosuppression

Keywords

pharmacokineticsdrug interactionsezetimibesirolimushuman experimentation

Outcome Measures

Primary Outcomes (1)

  • Primary characteristics: for ezetimibe: AUC0-∞, Cmax; for sirolimus: AUC0-∞, Cmax

    April 2007 to June 2007

Secondary Outcomes (1)

  • Second. characteristics: for ezetimibe: CLR, Ae (urine), Ae (feces); for ezetimibe glucuronide: AUC0-∞, Cmax, Ae (urine), Ae (feces); for ezetimibe, ezetimibe glucuronide and sirolimus: AUC0-t, t½, tmax

    April 2007 to June 2007

Study Arms (3)

A

ACTIVE COMPARATOR

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe)

Drug: 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany

B

ACTIVE COMPARATOR

administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)

Drug: 1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany

C

EXPERIMENTAL

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)

Drug: 1 tablet Ezetrol(R) + 1 tablet Rapamune(R)

Interventions

1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, GermanyDRUG

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling

Also known as: Ezetrol
A
1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, GermanyDRUG

administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling

Also known as: Rapamune
B
1 tablet Ezetrol(R) + 1 tablet Rapamune(R)DRUG

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling

Also known as: Ezetrol+Rapamune
C

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 18 - 45 years
  • sex: male and female
  • ethnic origin: Caucasian
  • body weight: 19 kg/m² to 27 kg/m²
  • good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
  • written informed consent

You may not qualify if:

  • known allergy to macrolide antibiotics
  • existing cardiac or hematological diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of ezetimibe and sirolimus
  • existing hepatic and renal diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of ezetimibe and sirolimus
  • existing gastrointestinal diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of ezetimibe and sirolimus
  • acute or chronic diseases which could affect drug absorption or metabolism
  • history of any serious psychological disorder
  • drug or alcohol dependence
  • positive drug or alcohol screening
  • smokers of 10 or more cigarettes per day
  • positive screening results for HIV, HBV and HCV
  • volunteers who are on a diet which could affect the pharmacokinetics of the drug
  • heavy tea or coffee drinkers (more than 1L per day)
  • lactation and pregnancy test positive or not performed
  • volunteers suspected or known not to follow instructions
  • volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Greifswald, 17487, Germany

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeSirolimus

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Werner Siegmund, Prof

    Department of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

April 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 22, 2008

Record last verified: 2008-02

Locations

DE(1)