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Drug Interaction Study Between Raltegravir And UK-453,061

NCT ID: NCT00784420

Last Updated: 2008-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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Drug Interaction, Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UK-453,061

Group Type ACTIVE_COMPARATOR

UK-453,061

Intervention Type DRUG

UK-453,061 1000 mg once daily for 10 days

Raltegravir

Group Type ACTIVE_COMPARATOR

Raltegravir

Intervention Type DRUG

Raltegravir 400 mg twice daily for 10 days

UK-453,061 plus Raltegravir

Group Type EXPERIMENTAL

UK-453,061

Intervention Type DRUG

UK-453,061 1000 mg once daily for 10 days

Raltegravir

Intervention Type DRUG

Raltegravir 400 mg twice daily for 10 days

Interventions

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UK-453,061

UK-453,061 1000 mg once daily for 10 days

Intervention Type DRUG

UK-453,061

UK-453,061 1000 mg once daily for 10 days

Intervention Type DRUG

Raltegravir

Raltegravir 400 mg twice daily for 10 days

Intervention Type DRUG

Raltegravir

Raltegravir 400 mg twice daily for 10 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271019&StudyName=Drug%20Interaction%20Study%20Between%20Raltegravir%20And%20UK-453%2C061

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

Other Identifiers

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A5271019

Identifier Type: -

Identifier Source: org_study_id