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

NCT ID: NCT00426452

Last Updated: 2009-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Vatalinib

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: STUDY_CHAIR

Novartis

Other Identifiers

CPTK787A2121

Identifier Type: -

Identifier Source: org_study_id