跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT05898984
NCT05898984已完成1 期

A Single Dose, Randomized, Open-label, 3-Way Cross-over Clinical Pharmacology Study, to Evaluate the Systemic Exposure of BDP, Beclomethasone 17-monoproprionate, Formoterol Fumarate, and Glycopyrronium Bromide, After Inhalation of the Fixed Combination BDP/FF/GB HFA pMDI (CHF 5993) at Two Different Strengths and of BDP Hydrofluoroalkane (HFA), in Healthy Volunteers.

Chiesi Farmaceutici S.p.A.2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年4月24日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
69
试验地点
2
主要终点
systemic exposure ( area under the concentration time curve from zero to time) to beclomethasone 17 monopropionate (B17MP), FF and GB
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized Metered Dose Inhaler), to assess the proportionality of systemic exposure to BDP and B17MP (17-Monoproprionate), and the systemic exposure to FF and GB with increasing doses of BDP.

The study includes a QVAR REDIHALER® arm too.

详细描述

The main purpose of this study is to evaluate the systemic exposure to B17MP, FF, and GB as the area under the concentration-time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) and maximum plasma concentration (Cmax) across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg).

The secondary purposes of the study are:

  1. To evaluate the pharmacokinetic profile of BDP and additional pharmacokinetic parameters of B17MP, FF, and GB across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg);
  2. To compare the exposure to BDP and B17MP between the high dose BDP/FF/GB (total daily dose [TDD]: 800/24/50 µg) and the highest US-approved dose of QVAR (TDD 800 µg).
  3. generate additional safety and tolerability information of the two CHF 5993 pDMI strengths, after a single dose.

Participation in the study will last for a maximum of 70 days for each subject (starting from randomization).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Subject's written informed consent ;
  • •18-55 years of age;
  • •Ability to understand the study procedures, the risks involved and ability to be trained to correctly use the inhalers.
  • •Body mass index of 19.0 to 30.0 kg/m2 (extremes inclusive), and body weight ≥50.0 kg;
  • •Non- or ex-smokers who smoked <5 pack-years and stopped smoking >1 year prior to screening;
  • •Good physical and mental status, determined based on the medical history and a general clinical examination;
  • •Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40 to 90 mmHg, systolic blood pressure (SBP) 90 to 140 mmHg
  • •12-Lead digitised electrocardiogram (ECG) in triplicate considered as normal (40 ≤ heart rate [HR] ≤110 beats per minute, 120 milliseconds [ms] ≤ PR interval [PR] ≤220 ms [PR ≤120 ms without a delta wave may be acceptable], QRS interval [QRS] ≤120 ms, and Fridericia corrected QT interval [QTcF] ≤450 ms for males and QTcF ≤470 ms for females).
  • •Lung function measurements within normal limits at screening: forced expiratory volume in the first second (FEV1) equal to or more than 80% of predicted for the subject's normal value according to the Global Lung Function Initiative, European Respiratory Society Task Force Lung Function Reference Values and FEV1/forced vital capacity ratio >0.
  • •Female subjects of non-chid bearing potential or females of childbearing potential with a negative pregnancy test and acceptable contraceptive methods.

排除标准

  • •Participation in another clinical study with an investigational drug in the 30 days or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment; longer and more appropriate time could be considered by the Investigator based on the terminal half-life (t1/2) and/or long-term toxicity of the previous investigational drug;
  • •Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorders that may interfere with successful completion of this protocol according to the Investigator's judgment;
  • •Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
  • •Positive urine test for cotinine.
  • •Intake of non-permitted concomitant medications in the predefined period prior to screening, or prior to randomisation or the subject is expected to take non-permitted concomitant medications during the study;
  • •Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or prior to randomisation;
  • •Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
  • •Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergics;
  • •For females only: pregnant or lactating women.
  • •Subjects receiving treatment with any drug known to have a well defined potential for hepatotoxicity.
  • •Subjects using e-cigarettes within 6 months before screening.
  • •Other Inclusion/exclusion criteria as defined by the protocol.

结局指标

主要结局

systemic exposure ( area under the concentration time curve from zero to time) to beclomethasone 17 monopropionate (B17MP), FF and GB

时间窗: From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB

CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI vs. CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI: To evaluate the systemic exposure to beclomethasone 17 monopropionate (B17MP), FF and GB as area under the concentration time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg).

systemic exposure (maximum plasma concentration (Cmax) ) to beclomethasone 17 monopropionate (B17MP), FF and GB

时间窗: From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB

CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI vs. CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI: To evaluate the systemic exposure to beclomethasone 17 monopropionate (B17MP), FF and GB as maximum plasma concentration (Cmax) across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg).

次要结局

  • maximum plasma concentration (Cmax) of BDP after a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • maximum plasma concentration (Cmax) of B17MPafter a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • t max of BDP of B17MPafter a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • Time to Cmax (t max) of BDP across two different dose strengths of CHF 5993(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • Time to t1/2 of B17MP, FF and GB across two different dose strengths of CHF 5993.(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • t max of BDP after a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • Time to t1/2 of B17MPafter a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • Change of systolic and diastolic Blood pressure(from pre-dose to 24hours post dose)
  • Area under the concentration time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) of BDP across two different dose strengths of CHF 5993(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • t max of BDP across two different dose strengths of CHF 5993(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • Area under the concentration-time curve from zero to infinity (AUC0-∞) of B17MPafter a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • Incidence of Adverse events(through study completion, an average of 90 days, screening phase inclusive)
  • Area under the concentration time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) of B17MP after a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg);(From pre-dose to 24 hours post dose)
  • Time to Cmax (t max) of B17MP, FF and GB across two different dose strengths of CHF 5993.(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • Area under the concentration time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) of BDP after a single inhaled dose of CHF 5993 BDP/FF/GB 200/6/12.5 μg and of BDP HFA (QVAR REDIHALER®, BDP 80 μg)(From pre-dose to 24 hours post dose)
  • Incidence of study drugs reactions(through study completion, an average of 90 days, screening phase inclusive)
  • Area under the concentration-time curve from zero to infinity (AUC0-∞) of B17MP, FF and GB across two different dose strengths of CHF 5993.(From pre-dose to 24 hours post dose for BDP/B17MP and from pre-dose to 72hours post dose for FF and GB)
  • Number of participants with abnormal laboratory test results(through study completion, an average of 90 days, screening phase inclusive)
  • Number of participants with abnormal results of physical examinations(through study completion, an average of 90 days, screening phase inclusive)
  • body temperature abnormal values(through study completion, an average of 90 days, screening phase inclusive)
  • 12-lead ECG(From Pre-dose to 75 minutes post dose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

终止
1 期
A Study of JNJ-64140284 in Healthy Male ParticipantsHealthy
NCT04566926Janssen Pharmaceutica N.V., Belgium33
已完成
1 期
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic GastroparesisDiabetes Mellitus Type 1 and 2Diabetes Mellitus ComplicationsGastrointestinal Motility DisorderGastroparesis
NCT01394055Motus Therapeutics, Inc.20
已完成
1 期
A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy ParticipantsHealthy
NCT01800682Janssen Research & Development, LLC30
终止
1 期
Study to Compare the Pharmacokinetics and Pharmacodynamics of ASA Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary FunctionObstructive Pulmonary FunctionRestrictive Pulmonary Function
NCT05625347Vectura, Inc.4
已完成
1 期
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy VolunteersHealthy
NCT02125227Yuhan Corporation56