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OpenTrials
Completed

NCT Number: NCT00426452

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

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

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Key information

Conditions

Healthy

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vatalinib

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2006
First posted
Jan 24, 2007
Registry last updated
Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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