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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Insmed Medical Information
- 전화번호: 18444467633
- 이메일: medicalinformation@insmed.com
연구 장소
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California
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Lake Forest, California, 미국, 92630
- 모병
- USA004
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San Dimas, California, 미국, 91773
- 모병
- USA003
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Florida
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Orlando, Florida, 미국, 32809
- 모병
- USA002
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Texas
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San Antonio, Texas, 미국, 78215
- 모병
- USA001
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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실험적: 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.
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Oral inhalation using a dry powder inhaler device.
다른 이름들:
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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Time to Maximum Observed Concentration (Tmax) of TP and TRE
기간: 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
|
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Apparent Volume of Distribution (Vz/F) of TP and TRE
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fraction Unbound (Fu) of TRE
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Study Director, Insmed Incorporated
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
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마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- INS1009-104
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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