A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
← catalyst calendarNCT07643155 · readout in 172 d
Sponsored by Insmed Incorporated (industry) · INSM — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
30estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-14 | actual | When the study began enrolling |
| Primary completion | 2027-02-07 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-07 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hepatic Impairment
Intervention
- Drug: Treprostinil Palmitil Inhalation Powder — also filed as INS1009
Primary outcomes
what the primary-completion date above is the date OFArea Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)
measured 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
measured Pre-dose and at multiple timepoints post-dose up to Day 3
Maximum Observed Plasma Concentration (Cmax) of TP and TRE
measured Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Total Clearance (CL/F) of TP and TRE
measured Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Terminal Elimination Half-Life (t1/2) of TP and TRE
measured Pre-dose and at multiple timepoints post-dose up to Day 3
Time to Maximum Observed Concentration (Tmax) of TP and TRE
measured Pre-dose and at multiple timepoints post-dose up to Day 3
Apparent Volume of Distribution (Vz/F) of TP and TRE
measured Pre-dose and at multiple timepoints post-dose up to Day 3
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