A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female Volunteers

This study has been completed.

First Received: January 23, 2007 Last Updated: November 18, 2009 History of Changes

Sponsor:	Novartis
Collaborator:	Bayer
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00426452

Purpose

This study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of Vatalinib under fasting and fed conditions.

Condition	Intervention	Phase
Healthy	Drug: Vatalinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Phase IB, Open Label, Single Center, Drug-drug Interaction Study of Oral 1250 mg of PTK787/ZK 222584 Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor (Omeprazole) in Healthy Sterile or Postmenopausal Female Volunteers

Resource links provided by NLM:

Drug Information available for: Omeprazole

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.

Secondary Outcome Measures:

Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.

Estimated Enrollment:	24
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female

Criteria

Inclusion criteria

Healthy female
Surgically sterile or post-menopausal
At least a weight of 50 kg and have a body mass index (BMI) ≤33.0
Non-smokers or those who smoke 25 cigarettes or less per day Exclusion criteria
Use of certain prescription and over the counter drugs
Having received an investigational drug within 30 days prior to dosing
Donation of plasma or donation or loss of whole blood prior to administration of the study medication
Any clinically significant laboratory tests
Abnormal cardiac function
A positive test for HIV, Hepatitis B or C
A positive alcohol test or drug test
Known allergy to Vatalinib or Omeprazole
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism and excretion or drugs.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426452

Sponsors and Collaborators

Novartis

Bayer

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CPTK787A2121
Study First Received:	January 23, 2007
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00426452 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor
Vatalinib
Proton-pump inhibitors
Omeprazole
Healthy Postmenopausal Female Volunteers

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010