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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1

Details

• Lead Sponsor: Novartis
• Collaborator: Bayer
• Treatments: Omeprazole; Proton Pump Inhibitors; Vatalanib

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