Drug Interaction Study Between Raltegravir And UK-453,061

Study Overview
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Brief Summary
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The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.

Official Title
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Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: UK-453,061
* Drug: UK-453,061
* Drug: Raltegravir
* Drug: Raltegravir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: UK-453,061<br> | Drug: UK-453,061<br>* UK-453,061 1000 mg once daily for 10 days<br>|
| Active Comparator: Raltegravir<br> | Drug: Raltegravir<br>* Raltegravir 400 mg twice daily for 10 days<br>|
| Experimental: UK-453,061 plus Raltegravir<br> | Drug: UK-453,061<br>* UK-453,061 1000 mg once daily for 10 days<br>Drug: Raltegravir<br>* 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 |
| --- | --- | --- |
| Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12 |  | 11 days | 
| UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24 |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h |  | 11 days | 
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments |  | 11 days | 
| UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h |  | 11 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Interaction, Pharmacokinetics