The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers. * Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal. * Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
125 mg
blinded, multiple ascending dose
ICON Development Solutions
San Antonio, Texas, United States
Safety
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
Time frame: 7 days
Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734
Change from baseline in: Pupillometry and Cold Pain Test
Time frame: 4 days
Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F. From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
Time frame: 4 days
Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms
Change from baseline in: Pupillometry and Cold Pain Test
Time frame: 7 days
Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F. From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
Time frame: 7 days
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TRV734-matched and oxycodone placebo