Drug Interaction Study Between Raltegravir And UK-453,061

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00784420
First received: September 30, 2008
Last updated: November 17, 2008
Last verified: November 2008
  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 1

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

Resource links provided by NLM:


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
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

  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

Additional Information:
No publications provided

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

Keywords provided by Pfizer:
Drug Interaction, Pharmacokinetics

ClinicalTrials.gov processed this record on April 16, 2014