This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Oral tablets 0.25mg, single dose
Oral tablets, 300 mg, single dose
Research Site
Overland Park, Kansas, United States
AUC for digoxin administered alone and in combination with vandetanib 300 mg
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose
Cmax for digoxin administered alone and in combination with vandetanib 300 mg
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 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 digoxin administered alone and in combination with vandetanib 300 mg
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose
Digoxin PK parameters for vandetanib in combination with digoxin
Time frame: Predose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72, and 96 hrs post dose
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