This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
16
Intravenous infusion
Intravenous infusion
Miami Research Associates
Miami, Florida, United States
Cmax
Maximum concentration in plasma following dosing on Day 1
Time frame: Day 1
Tmax
Time to maximum plasma concentration
Time frame: Day 1
t½
Time to 50% plasma concentration
Time frame: Day 1
AUC0-24
Area under the plasma concentration time curve through 24 hours after dosing.
Time frame: Day 1
AUC0-∞
Area under the concentration time curve from time 0 to infinity.
Time frame: Day 1
AUCtau
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Time frame: Day 1
Plasma Vz
Volume of distribution
Time frame: Day 1
Plasma CL
Plasma clearance
Time frame: Day 1
Cmax
Maximum plasma concentration
Time frame: Day 5
Tmax
Time to reach maximum plasma concentration.
Time frame: Day 5
t½
Time to 50% plasma concentration
Time frame: Day 5
AUC0-24
Area under the plasma concentration time curve 24 hours following the last dose.
Time frame: Day 5
AUC0-∞
Area under the plasma concentration time curve from 0 to infinity.
Time frame: Day 5
AUCtau
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Time frame: Day 5
Vss
Apparent volume of distribution at steady state
Time frame: Day 5
CLss
Apparent clearance
Time frame: Day 5
Number of Subjects With Adverse Events
Time frame: 1 week
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