The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Oral inhalation using a capsule-based dry powder inhaler device.
Oral inhalation using a capsule-based dry powder inhaler device.
ARG003
Barracas, Ciudad Autónoma de BuenosAires, Argentina
ARG001
Rosario, Santa Fe Province, Argentina
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 140
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Time frame: Up to Day 140
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Time frame: Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Cmax of Treprostinil
Time frame: Day 1 to Week 16
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Tmax of Treprostinil
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUCtau of Treprostinil
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From 0 to Infinity (AUC∞) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUC∞ of Treprostinil
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ARG008
Buenos Aires, Argentina
AUS003
Camperdown, New South Wales, Australia
AUS005
Macquarie Park, New South Wales, Australia
BEL002
Liège, Belgium
GER006
Heidelberg, Baden-Wurttemberg, Germany
GER010
Giessen, Hesse, Germany
GER003
Essen, North Rhine-Westphalia, Germany
GER001
Dresden, Saxony, Germany
...and 15 more locations
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUClast of Treprostinil
Time frame: Day 1 to Week 16
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
CL/F of Treprostinil
Time frame: Day 1 to Week 16
Elimination Half-life (t1/2) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
t1/2 of Treprostinil
Time frame: Day 1 to Week 16
Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Vd/F of Treprostinil
Time frame: Day 1 to Week 16