Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy men, age 18-50;
Healthy women of nonchildbearing potential, age 18-50.

Exclusion criteria

Treatment and study plan

Bosutinib

Drug

Bosutinib fasting

Primary outcomes

Pharmacokinetics (plasma concentrations)

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jul 24, 2008
Registry last updated: Feb 6, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed