Treprostinil Palmitil Inhalation Powder
DrugOral inhalation using a dry powder inhaler device.
Other names: INS1009
NCT Number: NCT07643155
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Participants with Normal Hepatic Function
Inclusion criteria
for Participants With Hepatic Impairment:
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.
Oral inhalation using a dry powder inhaler device.
Other names: INS1009
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 3
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
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
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
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
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
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
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 on Days 1 and 2
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: Up to Day 7
Evaluation of safety and tolerability of a single dose of TPIP in participants with mild, moderate, and severe hepatic impairment and normal hepatic function.
Contact information is provided by the study sponsor or research team.
Insmed Incorporated
Industry
An Open-label, Phase 1 Trial to Evaluate the Pharmacokinetics and Safety of a Single Dose of 80 μg Treprostinil Palmitil Inhalation Powder in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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