The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
Change from Baseline in Pulmonary Vascular Resistance at Week 16
Time frame: Baseline to Week 16
Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16
Percent Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16
Number of Participants Who Experience a Treatment-emergent Adverse Event (AE)
Time frame: Day 1 up to Week 20
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Evaluations
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Physical Examinations
Time frame: Baseline to Week 16
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
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USA025
Phoenix, Arizona, United States
USA022
Scottsdale, Arizona, United States
USA021
Tucson, Arizona, United States
USA023
Sacramento, California, United States
USA002
West Hollywood, California, United States
USA008
Gainesville, Florida, United States
USA005
Jacksonville, Florida, United States
USA007
Orlando, Florida, United States
USA011
Tampa, Florida, United States
USA010
Winter Park, Florida, United States
...and 82 more locations
Maximum Plasma Concentration (Cmax) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Change from Baseline in the Concentration of N-Terminal-Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Levels at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16 or end of study