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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014