Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
2014년 10월 13일 업데이트: Boehringer Ingelheim
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 Healthy Male Volunteers
- To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers
- To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
12
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
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- 50 to 65 years of age
- Body Mass Index (BMI) of 19.9 to 29.9 kg/m2
- Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm
- All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Exclusion Criteria:
- Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders
- Diseases of the central nervous system or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within 2 months prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range and of clinical relevance
- Inability to comply with dietary regimen of study centre
Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the drugs under study or for the study:
- Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
- ECG: PR interval > 210 ms
- HR at rest ≤ 55 beats per minute (bpm)
- Relevant ophthalmological disease
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: [14C]-DK-AH 269 CL intravenous
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실험적: [14C]-DK-AH 269 CL oral
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum measured concentration of the analytes in plasma (Cmax)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Area under the concentration-time curve of the analytes in plasma (AUC)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Time from dosing to the maximum concentration of the analytes in plasma (tmax)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Terminal rate constant of the analytes in plasma (λz)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Terminal half-life of the analytes in plasma (t1/2)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Mean residence time of the analytes in the body after intravenous administration (MRT)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Mean residence time of the analytes in the body after oral administration (MRTpo)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
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Total clearance of the analytes in plasma following intravascular administration (CL)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Volume of distribution at steady state (Vss)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
기간: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
|
|
Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
기간: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
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|
Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
기간: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
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|
Fraction of dose absorbed, based on radioactivity data (Fa)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Absolute bioavailability of the analytes after oral administration (F)
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Ratio of CBlood cells/Cplasma [14C]-radioactivity
기간: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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Number of patients with clinically significant findings in vital signs
기간: up to 12 days after last drug administration
|
blood pressure, heart rate
|
up to 12 days after last drug administration
|
|
Number of patients with clinically significant findings in 12-lead ECG
기간: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
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Number of patients with clinically significant findings in 2-lead ECG (telemetry)
기간: up to 90 minutes after start of treatment
|
up to 90 minutes after start of treatment
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Clinically significant changes from baseline in physical examination
기간: Pre-dose, and 12 days after last drug administration
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Pre-dose, and 12 days after last drug administration
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Occurrence of visual phenomena
기간: up to 120 hours after start of treatment
|
questionnaire
|
up to 120 hours after start of treatment
|
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Number of patients with clinically significant findings in clinical laboratory tests
기간: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
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
2004년 3월 1일
기본 완료 (실제)
2004년 4월 1일
연구 등록 날짜
최초 제출
2014년 10월 13일
QC 기준을 충족하는 최초 제출
2014년 10월 13일
처음 게시됨 (추정)
2014년 10월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 10월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 10월 13일
마지막으로 확인됨
2014년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 503.209
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