CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Ezetrol (ezetimibe) multiple dose +3 moredrug
Likely dose
Ezetrol (ezetimibe) multiple dose 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00810303
NCT00810303Phase 1Completed
CompareCT.gov

Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2

University Medicine Greifswald·interventional·Posted Dec 18, 2008·Updated Oct 11, 2010

In Brief

A Phase 1 clinical trial evaluating Ezetrol (ezetimibe) multiple dose, Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose, and 2 other interventions for Pharmacokinetics and 3 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Drug Interactions, Pharmacodynamics, Intestinal Transporter Expression
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2008
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.5 years ago

Interventions

Ezetrol (ezetimibe) multiple dosedrug

administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15))

Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dosedrug

administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20)

Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dosedrug

administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30)

Sustiva (efavirenz) single dosedrug

administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)