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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

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NCT07643155 · 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
DateFiledBasisWhat it is
Start2026-07-14actualWhen the study began enrolling
Primary completion2027-02-07estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-02-07estimatedThe whole study's end, after follow-up
First posted2026-06-11actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-11actualThe 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 OF
Area 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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