- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02259959
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
2014년 10월 7일 업데이트: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2 μg/5 μg, 10 μg/5 μg, and 40 μg/10 μg) of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide for 14 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
36
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease
- Age ≥21 and ≤45 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 40 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
The following exclusion criteria are specific for this study due to the known class side effect profile of Tiotropium:
- Hypersensitivity to tiotropium and/or related drugs of these classes
- History of narrow-angle glaucoma
- History of prostatic hyperplasia
- History of bladder-neck obstruction
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: 위약
|
|
실험적: BI 1744 CL in combination with Tiotropium
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of subjects with clinically relevant findings in physical examination
기간: Up to day 32
|
Up to day 32
|
|
Number of subjects with clinically relevant findings in vital signs
기간: Up to day 32
|
blood pressure, pulse rate
|
Up to day 32
|
Number of subjects with clinically relevant findings in 12-lead ECG
기간: Up to day 32
|
Up to day 32
|
|
Number of subjects with clinically relevant findings in laboratory tests
기간: Up to day 32
|
Up to day 32
|
|
Number of subjects witch clinically relevant changes in additional safety laboratory test parameters
기간: up to 318 hours after start of treatment
|
Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium
|
up to 318 hours after start of treatment
|
Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography
기간: Pre-dose, up to 408 hours after start of treatment
|
Pre-dose, up to 408 hours after start of treatment
|
|
Number of subjects with adverse events
기간: Up to day 32
|
Up to day 32
|
|
Global assessment of tolerability by investigator on a 4-point scale
기간: Up to day 32
|
Up to day 32
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Maximum concentration in plasma (Cmax)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Time from dosing to maximum concentration in plasma (tmax)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Area under the concentration-time curve in plasma (AUC)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Terminal rate constant in plasma (λz)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Terminal half-life in plasma (t½)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Mean residence time in the body after inhalation (MRTih)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Apparent clearance after extravascular administration (CL/F)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Amount eliminated in urine from the time point t1 to t2 (Aet1-t2)
기간: up to 336 hours after start of treatment
|
up to 336 hours after start of treatment
|
Fraction excreted in urine from time point t1 to t2 (fet1-t2)
기간: up to 336 hours after start of treatment
|
up to 336 hours after start of treatment
|
Renal clearance from the time point t1 until the time point t2 (CLR,t1-t2)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Minimum measured concentration in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Predose concentration of the analytes in plasma at steady state immediately before administration of the next dose (Cpre,ss)
기간: Pre-dose every 24 hours
|
Pre-dose every 24 hours
|
Time of last measurable concentration in plasma (tz)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Linearity index (LI)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Accumulation ratio based on Cmax (RA,Cmax)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Accumulation ratio based on AUCτ (RA,AUC)
기간: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 4월 1일
기본 완료 (실제)
2007년 9월 1일
연구 등록 날짜
최초 제출
2014년 10월 7일
QC 기준을 충족하는 최초 제출
2014년 10월 7일
처음 게시됨 (추정)
2014년 10월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 10월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 10월 7일
마지막으로 확인됨
2014년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1237.2
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
위약에 대한 임상 시험
-
AJU Pharm Co., Ltd.OM Pharma SA모병
-
University Hospital, Strasbourg, France모집하지 않고 적극적으로