Raltegravir and Ezetimibe PK Study

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

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

Conditions
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HIV

Intervention / Treatment
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* Drug: Raltegravir and ezetimibe
* Drug: Ezetimibe and raltegravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Raltegravir and ezetimibe<br>* 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<br>|
| Active Comparator: 2<br> | Drug: Ezetimibe and raltegravir<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state plasma concentrations of raltegravir and ezetimibe when given alone and in combination |  | 41 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of raltegravir and ezetimibe co-administration. Association between genetic polymorphisms in drug disposition genes and drug exposure. |  | 41 days |