Study in healthy volunteers to assess effect of omeprazole and ranitidine on the pharmacokinetics of vandetanib
A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination with Omeprazole or Ranitidine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
Oral tablets, 300 mg, single dose
Oral capsules, 40 mg, multiple doses
Oral tables, 150 mg, multiple doses
Research Site
Overland Park, Kansas, United States
Cmax for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Cmax for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
AUC(0-t) for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
Frequency and severity of adverse events
Time frame: Treatment period + 7-14 days
ECG data
Time frame: Treatment period + 7-14 days
Laboratory data
Time frame: Treatment period + 7-14 days
Vital signs data
Time frame: Treatment period + 7-14 days
Other PK parameters for a single dose of vandetanib alone and in combination with omeprazole (PPI)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose
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Other PK parameters for a single dose of vandetanib alone and in combination with ranitidine (histamine antagonist)
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216,240,336,504 ,672 hrs post dose