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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Vatalinib

• Study Type: Interventional
• Enrollment: 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2006

Study Registration Dates

• First Submitted: January 23, 2007
• First Submitted That Met QC Criteria: January 23, 2007
• First Posted (Estimate): January 24, 2007

Study Record Updates

• Last Update Posted (Estimate): November 19, 2009
• Last Update Submitted That Met QC Criteria: November 18, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Omeprazole; Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor; Vatalinib; Proton-pump inhibitors; Healthy Postmenopausal Female Volunteers
• Additional Relevant MeSH Terms: Infertility; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Vatalanib
• Other Study ID Numbers: CPTK787A2121