Raltegravir and Ezetimibe PK Study

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772551
• Other study ID #: SSAT027
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2008
• Last updated: August 13, 2010
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: August 2010
• Source: St Stephens Aids Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
St Stephens Aids Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination		41 days
Secondary	Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure.		41 days