NCT00426452

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

First QC Date

January 23, 2007

Last Update Submit

November 18, 2009

Conditions

Healthy

Keywords

Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitorVatalinibProton-pump inhibitorsOmeprazoleHealthy Postmenopausal Female Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

VatalinibDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female
  • Surgically sterile or post-menopausal
  • At least a weight of 50 kg and have a body mass index (BMI) ≤33.0

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

vatalanib

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

July 1, 2006

Last Updated

November 19, 2009

Record last verified: 2009-11