Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects - Full Text View

Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00498745

Purpose

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Condition	Intervention	Phase
Healthy	Drug: HKI-272	Phase I

ChemIDplus related topics:

HKI-272

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Uncontrolled, Crossover Assignment

Official Title:	A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.

Estimated Enrollment:	36
Study Start Date:	July 2007
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Criteria:

Healthy male and female subjects aged 18 to 50 years.
Women of nonchildbearing potential (WONCBP)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498745

Locations


United States, Texas

	San Antonio, Texas, United States, 78217

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	3144A1-1109
First Received:	July 9, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00498745
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 06, 2008