Drug Interaction Study Between Raltegravir And UK-453,061

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: UK-453,061; Drug: Raltegravir

• Registration Number: NCT00784420
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-30
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Last Update Submitted: 2008-11-17
• Last Update Posted: 2008-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UK-453,061 plus Raltegravir	UK-453,061	-
UK-453,061	UK-453,061	-
Raltegravir	Raltegravir	-
UK-453,061 plus Raltegravir	Raltegravir	-

Primary Outcome Measures

Name	Time	Method
Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12	11 days
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24	11 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States