Clinical trial NCT00772551: Raltegravir and Ezetimibe PK Study
Official title: Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Lead sponsor: St Stephens Aids Trust
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination
timeFrame: 41 days
Secondary outcomes:
measure: Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure.
timeFrame: 41 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
Study officials:
affiliation: St Stephen's AIDS Trust
name: Marta Boffito
role: PRINCIPAL_INVESTIGATOR
References: