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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426452

Enrollment

Registered

2007-01-24

Start date

2006-07-31

Completion date

Unknown

Last updated

2009-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor, Vatalinib, Proton-pump inhibitors, Omeprazole, Healthy Postmenopausal Female Volunteers

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.

Interventions

DRUGVatalinib

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 70 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026