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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 AUC12

UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24

Secondary outcome:

Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h

Safety 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

Page last updated: August 23, 2015

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