Drug Interaction Study Between Raltegravir And UK-453,061
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: UK-453,061 (Drug); UK-453,061 (Drug); Raltegravir (Drug); Raltegravir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24
Secondary outcome: Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12hSafety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511-5473, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2008
Last updated: November 17, 2008
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