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Completed

NCT Number: NCT00772551

Raltegravir and Ezetimibe PK Study

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

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Key information

Conditions

HIV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raltegravir and ezetimibe

Drug

Group 1: raltegravir 400 mg orally twice daily for 10 days followed by 10 days of raltegravir 400 mg twice daily and ezetimibe 10 mg orally once daily for 10 days followed by a 10 days wash out period and ezetimibe 10 mg once daily for 10 days

Ezetimibe and raltegravir

Drug

Group2: ezetimibe 10 mg orally once daily for 10 days followed by ezetimibe 10 mg and raltegravir 400 mg orally twice daily for 10 days followed by a 10 days wash out period and raltegravir 400 mg twice daily for 10 days

Primary outcomes

  1. Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination

    Time frame: 41 days

Secondary outcomes

  1. Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure.

    Time frame: 41 days

Sponsors and collaborators

Lead sponsor

St Stephens Aids Trust

Other

Registry information

Official study title

Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2008
Registry last updated
Aug 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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