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
2026年6月8日 更新者:Insmed Incorporated
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
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.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Insmed Medical Information
- 電話番号:18444467633
- メール:medicalinformation@insmed.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Group 1: Treprostinil Palmitil Inhalation Powder
Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
|
Oral inhalation using a dry powder inhaler device.
他の名前:
|
|
実験的: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.
他の名前:
|
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実験的: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.
他の名前:
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実験的: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.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)
時間枠: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.
|
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
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
|
Maximum Observed Plasma Concentration (Cmax) of TP and TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
|
Apparent Total Clearance (CL/F) of TP and TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
|
Apparent Terminal Elimination Half-Life (t1/2) of TP and TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
|
Time to Maximum Observed Concentration (Tmax) of TP and TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
|
Apparent Volume of Distribution (Vz/F) of TP and TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose up to Day 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fraction Unbound (Fu) of TRE
時間枠: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.
|
Pre-dose and at multiple timepoints post-dose on Days 1 and 2
|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
時間枠: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.
|
Up to Day 7
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター:Study Director、Insmed Incorporated
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月10日
一次修了 (推定)
2027年2月7日
研究の完了 (推定)
2027年2月7日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- INS1009-104
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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Treprostinil Palmitil Inhalation Powderの臨床試験
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Insmed Incorporated利用可能肺動脈高血圧 | 肺高血圧、間質性肺疾患