This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
111
ICON Development Solutions
San Antonio, Texas, United States
Adverse events
Time frame: 28 days max
Cmax
Pharmacokinetics
Time frame: 28 days max
Tmax
Pharmacokinetics
Time frame: 28 days max
AUC
Pharmacokinetics
Time frame: 28 days max
T1/2
Pharmacokinetics
Time frame: 28 days max
Food effect on AUC value
Measure difference between fasted and fed doses
Time frame: 15 days max
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