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

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Vatalinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00426452

CPTK787A2121

Details and patient eligibility

About

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

Sex

Female

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.