Status:
COMPLETED
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
Lead Sponsor:
Novartis
Collaborating Sponsors:
Bayer
Conditions:
Healthy
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00426452
Start Date
July 1 2006
Last Update
November 19 2009
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