Drug Interaction Study Between Raltegravir And UK-453,061

Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: UK-453,061; Drug: Raltegravir

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UK-453,061	Drug: UK-453,061; UK-453,061 1000 mg once daily for 10 days
Active Comparator: Raltegravir	Drug: Raltegravir; Raltegravir 400 mg twice daily for 10 days
Experimental: UK-453,061 plus Raltegravir	Drug: UK-453,061; UK-453,061 1000 mg once daily for 10 days; Drug: Raltegravir; Raltegravir 400 mg twice daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12	11 days
UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24	11 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: November 3, 2008
• First Posted (Estimate): November 4, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2008
• Last Update Submitted That Met QC Criteria: November 17, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Drug Interaction, Pharmacokinetics
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium
• Other Study ID Numbers: A5271019