A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
78
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom
Incidence of Treatment-Emergent Adverse Events
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
Time frame: one to seven days
Maximum Observed Plasma Concentration (Cmax)
Time frame: one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
Comparative pharmacokinetics of single dose administered in a fasted state and following a meal
Time frame: one to seven days
Terminal elimination half-life (t½)
Time frame: one to seven days
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