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Completed

NCT Number: NCT00784420

Drug Interaction Study Between Raltegravir And UK-453,061

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UK-453,061

Drug

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

raltegravir

Drug

Raltegravir 400 mg twice daily for 10 days

Primary outcomes

  1. Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12

    Time frame: 11 days

  2. UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24

    Time frame: 11 days

Secondary outcomes

  1. Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h

    Time frame: 11 days

  2. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments

    Time frame: 11 days

  3. UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h

    Time frame: 11 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 4, 2008
Registry last updated
Nov 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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