Drug Interaction Study Between Raltegravir And UK-453,061 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00784420

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: UK-453,061 Drug: Raltegravir	Phase I

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24 [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments [ Time Frame: 11 days ] [ Designated as safety issue: No ]
UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	September 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
UK-453,061: Active Comparator	Drug: UK-453,061 UK-453,061 1000 mg once daily for 10 days
Raltegravir: Active Comparator	Drug: Raltegravir Raltegravir 400 mg twice daily for 10 days
UK-453,061 plus Raltegravir: Experimental	Drug: UK-453,061 UK-453,061 1000 mg once daily for 10 days Drug: Raltegravir Raltegravir 400 mg twice daily for 10 days

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784420

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5271019
Study First Received:	September 30, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00784420
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Drug Interaction, Pharmacokinetics

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009