The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Unnamed facility
San Antonio, Texas, United States
Evaluate the maximum observed plasma concentration (Cmax)
Time frame: 9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)
Time frame: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
Time frame: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
Time frame: 9-days
Evaluate the apparent elimination half-life (t1/2)
Time frame: 9-days
Evaluate the apparent clearance (CL/F)
Time frame: 9-days
Safety and tolerability as measured by adverse events
Time frame: 9-days
Safety and tolerability as measured by clinical observations
Time frame: 9-days
Safety and tolerability as measured by 12-lead ECGs
Time frame: 9-days
Safety and tolerability as measured by cardiac telemetry monitoring
Time frame: 9-days
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
Time frame: 9-days
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Safety and tolerability as measured by oxygen saturation
Time frame: 9-days
Safety and tolerability as measured by safety laboratory tests
Time frame: 9-days