Raltegravir and Ezetimibe PK Study

Phase 1

Completed

• Conditions: HIV
• Interventions: Drug: Ezetimibe and raltegravir; Drug: Raltegravir and ezetimibe

• Registration Number: NCT00772551
• Lead Sponsor: St Stephens Aids Trust

Brief Summary

Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
• Male or non-pregnant, non-lactating females
• Between 18 to 65 years, inclusive
• Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria

• Any significant acute or chronic medical illness
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
• Positive blood screen for hepatitis B and/or C antibodies
• Positive blood screen for HIV-1 and 2 antibodies
• Current or recent (within 3 months) gastrointestinal disease
• Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
• Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
• Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
• Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
• Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
• Previous allergy to any of the constituents of the pharmaceuticals administered in this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Ezetimibe and raltegravir	-
1	Raltegravir and ezetimibe	-

Primary Outcome Measures

Name	Time	Method
Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination	41 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure.	41 days

Trial Locations

Locations (1)

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom