This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Comprehensive Clinical Development
Miramar, Florida, United States
Tolerability of repeat dosing of velusetrag
Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs
Time frame: 3 weeks
Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite
Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve)
Time frame: Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose)
Profile of urine PK of velusetrag and metabolite
Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance)
Time frame: Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose
Pharmacodynamic effects of velusetrag
weekly bowel movement frequency
Time frame: 3 weeks
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