A Phase 1 interventional study of Treprostinil Palmitil Inhalation Powder in Hepatic Impairment, sponsored by Insmed Incorporated. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Insmed Incorporated · Phase 1, Interventional, and Treatment
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.
Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for Participants with Normal Hepatic Function
Inclusion Criteria for Participants With Hepatic Impairment:
Participants with type 2 diabetes mellitus may be included, if they have:
Exclusion Criteria:
Exclusion Criteria for Participants with Normal Hepatic Function
Exclusion Criteria for Participants With Hepatic Impairment:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
Drug: Treprostinil Palmitil Inhalation Powder
Participants with mild hepatic impairment (classified based on the numerical Child-Pugh total score of 5 to 6) will receive a single dose of TPIP on Day 1.
Drug: Treprostinil Palmitil Inhalation Powder
Participants with moderate hepatic impairment (classified based on the numerical Child-Pugh total score of 7 to 9) will receive a single dose of TPIP on Day 1.
Drug: Treprostinil Palmitil Inhalation Powder
Participants with severe hepatic impairment (classified based on the numerical Child-Pugh total score of 10 to 15) will receive a single dose of TPIP on Day 1.
Drug: Treprostinil Palmitil Inhalation Powder
Oral inhalation using a dry powder inhaler device.
Also known as: INS1009
Area 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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Treprostinil hexadecyl ester