Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

This study has been completed.

First Received: March 11, 2009 Last Updated: April 24, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00860223

Purpose

The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.

Condition	Intervention	Phase
Healthy	Drug: Digoxin Drug: Neratinib	Phase I

Drug Information available for: Digoxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetic parameters: concentration of digoxin in blood and urine [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Digoxin alone	Drug: Digoxin
2: Experimental Digoxin plus neratinib	Drug: Digoxin Drug: Neratinib

Eligibility

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

Criteria

Inclusion criteria:

Healthy men and women of non-childbearing potential, age 18-50

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860223

Locations

United States, Florida

Miami, Florida, United States, 33126

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3144A1-1119
Study First Received:	March 11, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00860223 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy Subjects

Study placed in the following topic categories:

Digoxin
Anti-Arrhythmia Agents
Cardiovascular Agents
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs
Digoxin

Enzyme Inhibitors
Anti-Arrhythmia Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009