Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
One time dosing in capsule formulation
One time dosing in capsule formulation
Celerion
Lincoln, Nebraska, United States
Safety and tolerability of TD-0714 by assessing the number, severity and type of adverse events, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs
Time frame: From Day 1 through end of study (Day 10)
Pharmacokinetics (PK) of TD-0714 in plasma after a single-dose (SD): peak plasma concentration (Cmax)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: time to peak plasma concentration (Tmax)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: time to last measurable concentration (Tlast)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)
Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)
PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to infinity (AUC0-∞)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: Vz/F (apparent volume of distribution during the terminal phase)
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Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in plasma after a SD: t1/2 (half-life)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in urine after a SD: Ae (amount excreted in urine)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in urine after a SD: Fe (fraction of oral dose excreted in urine)
Time frame: Day 1 through end of study (Day 10)
PK of TD-0714 in urine after a SD: Clr (renal clearance)
Time frame: Day 1 through end of study (Day 10)