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.
Sponsor:
Collaborator:
Bayer
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426452
First received: January 23, 2007
Last updated: November 18, 2009
Last verified: November 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00426452     History of Changes
Other Study ID Numbers: CPTK787A2121
Study First Received: January 23, 2007
Last Updated: November 18, 2009
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:
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014