Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy adult and elderly subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Celerion
Lincoln, Nebraska, United States
The number of adverse events by severity, 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-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 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 to 3 days after last dose (Day 17)
PK of TD-1439 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 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)
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Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)
Time frame: Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in urine after multiple doses - Clr (renal clearance)
Time frame: Day 1 to 3 days after last dose (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 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)