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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

NCT ID: NCT00426452

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Vatalinib

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Other Identifiers

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CPTK787A2121

Identifier Type: -

Identifier Source: org_study_id