NCT00784420CompletedPhase 1
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
UK-453,061 plus Raltegravir
Experimental
Intervention: Raltegravir (Drug)
UK-453,061
Active Comparator
Intervention: UK-453,061 (Drug)
Raltegravir
Active Comparator
Intervention: Raltegravir (Drug)
UK-453,061 plus Raltegravir
Experimental
Intervention: UK-453,061 (Drug)
Outcomes
Primary Outcomes
Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12
Time Frame: 11 days
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24
Time Frame: 11 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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