The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Oral syrup 7.5 mg, single dose
Oral tablets, 800 mg, single dose
Research Site
Overland Park, Kansas, United States
AUC for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Cmax for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Frequency and severity of adverse events
Time frame: Treatment period from 7 to 14 days
ECG data
Time frame: Treatment period from 7 to 14 days
Laboratory data
Time frame: Treatment period from 7 to 14 days
Vital signs data
Time frame: Treatment period from 7 to 14 days
Other PK parameters for midazolam administered alone and in combination with vandetanib 800 mg
Time frame: Predose,0.5,1,1.5,2,3,4,6,8,12,16,24,30,36,48 hrs post dose
Vandetanib PK parameters for vandetanib in combination with midazolam
Time frame: Predose,1,2,3,4,5,6,7,8,10,12,18,24,36,48,72,96,120,144,168,192,216 hrs post dose
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