The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral inhalation using a dry powder inhaler device.
USA004
Lake Forest, California, United States
RECRUITINGUSA003
San Dimas, California, United States
RECRUITINGUSA002
Orlando, Florida, United States
RECRUITINGUSA001
San Antonio, Texas, United States
RECRUITINGArea Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Maximum Observed Plasma Concentration (Cmax) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Total Clearance (CL/F) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Terminal Elimination Half-Life (t1/2) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Time to Maximum Observed Concentration (Tmax) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Volume of Distribution (Vz/F) of TP and TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
Fraction Unbound (Fu) of TRE
Determination of the effect of mild, moderate, and severe hepatic impairment on the unbound PK of TRE following a single dose of TPIP, when compared to normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 2
Number of Participants Who Experienced At Least One Adverse Event (AE)
Evaluation of safety and tolerability of a single dose of TPIP in participants with mild, moderate, and severe hepatic impairment and normal hepatic function.
Time frame: Up to Day 7
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