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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00426452
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.