Raltegravir and Ezetimibe PK Study

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00772551
First received: October 10, 2008
Last updated: August 13, 2010
Last verified: August 2010

October 10, 2008
August 13, 2010
June 2008
August 2008   (final data collection date for primary outcome measure)
Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination [ Time Frame: 41 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00772551 on ClinicalTrials.gov Archive Site
Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure. [ Time Frame: 41 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Raltegravir and Ezetimibe PK Study
Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: Raltegravir and ezetimibe
    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
  • Drug: Ezetimibe and raltegravir
    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
  • Active Comparator: 1
    Intervention: Drug: Raltegravir and ezetimibe
  • Active Comparator: 2
    Intervention: Drug: Ezetimibe and raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00772551
SSAT027
No
Dr Marta Boffito, St Stephen's AIDS Trust
St Stephens Aids Trust
Not Provided
Principal Investigator: Marta Boffito St Stephen's AIDS Trust
St Stephens Aids Trust
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP