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

Condition(s) targeted: Healthy

Intervention: Vatalinib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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

Official title: 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

Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Primary outcome: 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: 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.

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Female.

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

Starting date: June 2006
Last updated: January 23, 2007