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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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vatalinib
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor, Vatalinib, Proton-pump inhibitors, Omeprazole, Healthy Postmenopausal Female Volunteers

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)Female

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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    January 23, 2007
    Last Updated
    November 18, 2009
    Sponsor
    Novartis
    Collaborators
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00426452
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis
    Collaborators
    Bayer

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor, Vatalinib, Proton-pump inhibitors, Omeprazole, Healthy Postmenopausal Female Volunteers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Vatalinib
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    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

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