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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014