Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy adult and elderly subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
50
Celerion
Lincoln, Nebraska, United States
Safety of TD-0714 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Time frame: From Day 1 through end of study (Day 25)
Pharmacokinetics (PK) of TD-0714 in plasma after multiple doses - peak plasma concentration (Cmax)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to last measurable concentration (Tlast)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - CL/F (oral plasma clearance)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)
Time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - t1/2 (half-life)
Time frame: Day 1 through Day 17
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PK of TD-0714 in urine after multiple doses - Ae (amount excreted in urine)
Time frame: Day 1 through Day 17
PK of TD-0714 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)
Time frame: Day 1 through Day 17
PK of TD-0714 in urine after multiple doses - Clr (renal clearance)
Time frame: Day 1 through Day 17
Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)