- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07643155
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
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Insmed Medical Information
- Telefonszám: 18444467633
- E-mail: medicalinformation@insmed.com
Tanulmányi helyek
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California
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Lake Forest, California, Egyesült Államok, 92630
- Toborzás
- USA004
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San Dimas, California, Egyesült Államok, 91773
- Toborzás
- USA003
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Florida
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Orlando, Florida, Egyesült Államok, 32809
- Toborzás
- USA002
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Texas
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San Antonio, Texas, Egyesült Államok, 78215
- Toborzás
- USA001
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m^2), inclusive.
Inclusion Criteria for Participants with Normal Hepatic Function
- In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, as assessed by the investigator (or designee).
Inclusion Criteria for Participants With Hepatic Impairment:
- Diagnosis of chronic (>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.
Participants with type 2 diabetes mellitus may be included, if they have:
- glycosylated hemoglobin A1C ≤8.5% at screening
- fasting blood glucose ≤240 milligrams per deciliter (mg/dL), while participant is using their normal diabetes medication, at screening and check-in.
Exclusion Criteria:
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).
- Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.
- Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
Exclusion Criteria for Participants with Normal Hepatic Function
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary.
Exclusion Criteria for Participants With Hepatic Impairment:
- Current organ transplant or waiting for organ transplant scheduled to occur during the trial.
- Hospitalization for hepatic encephalopathy within 3 months prior to dosing.
- Encephalopathy ≥Grade 2.
- History of drug/chemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Group 1: Treprostinil Palmitil Inhalation Powder
Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
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Oral inhalation using a dry powder inhaler device.
Más nevek:
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Kísérleti: Group 2: 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.
|
Oral inhalation using a dry powder inhaler device.
Más nevek:
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Kísérleti: Group 3: 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.
|
Oral inhalation using a dry powder inhaler device.
Más nevek:
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Kísérleti: Group 4: 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.
|
Oral inhalation using a dry powder inhaler device.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Maximum Observed Plasma Concentration (Cmax) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Apparent Total Clearance (CL/F) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Apparent Terminal Elimination Half-Life (t1/2) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Time to Maximum Observed Concentration (Tmax) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
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Pre-dose and at multiple timepoints post-dose up to Day 3
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Apparent Volume of Distribution (Vz/F) of TP and TRE
Időkeret: Pre-dose and at multiple timepoints post-dose up to Day 3
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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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Fraction Unbound (Fu) of TRE
Időkeret: Pre-dose and at multiple timepoints post-dose on Days 1 and 2
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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.
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Pre-dose and at multiple timepoints post-dose on Days 1 and 2
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Number of Participants Who Experienced At Least One Adverse Event (AE)
Időkeret: Up to Day 7
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Evaluation of safety and tolerability of a single dose of TPIP in participants with mild, moderate, and severe hepatic impairment and normal hepatic function.
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Up to Day 7
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: Study Director, Insmed Incorporated
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- INS1009-104
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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