Pfizer Investigational Site
Brussels, B-1070, Belgium
NCT Number: NCT01549574
This is an open-label, randomized, cross-over, single dose study in healthy volunteers to evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of crioztinib with or without esomeprazole separated by a washout period of at least 14 days.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brussels, B-1070, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5
Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Pfizer
Industry
A Phase 1, Open Label, Single Dose, Randomized, Cross-Over Study To Estimate The Effect Of Esomeprazole On The Pharmacokinetics Of Crizotinib In Healthy Volunteers
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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