Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Richmond Pharmacology Ltd
London, United Kingdom
Part 1: Maximum Observed Concentration (Cmax) of SYT-510
Time frame: Up to 72 hours post-dose
Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510
Time frame: Up to 72 hours post-dose
Part 1: AUC of SYT-510
Time frame: Up to several days post last dose
Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510
Time frame: Up to Day 20
Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510
Time frame: Up to Day 4
Part 2: Maximum observed concentration (Cmax) of SYT-510
Time frame: Up to Day 14
Part 2: Time of maximal plasma concentration (tmax) of SYT-510
Time frame: Up to Day 14
Part 2: AUCtau of SYT-510
Time frame: Up to Day 14
Part 2: Terminal elimination half-life (t1/2) of SYT-510
Time frame: Up to several days post last dose
Part 2: Accumulation ratio of SYT-510
Time frame: Up to Day 14
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Oral formulation