- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05451095
A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine
A Randomized, Placebo Controlled, Double-blind, Double-dummy, Three-way Crossover Trial to Investigate the Effect of Two Doses of BI 474121 on Ketamine Induced Cognitive Deficits in Healthy Male Subjects
연구 개요
연구 유형
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 32 kg/m2 (inclusive)
- Signed and dated written informed consent(s) prior to admission to the study, in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended
Exclusion Criteria:
- Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm evaluated as clinically significant by Investigators
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment sequence T1-T2-R
T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion
|
위약
BI 474121
Ketamine hydrochloride
|
|
실험적: 치료 순서 T2-T1-R
|
위약
BI 474121
Ketamine hydrochloride
|
|
실험적: 치료 순서 T1-R-T2
|
위약
BI 474121
Ketamine hydrochloride
|
|
실험적: 치료 순서 T2-R-T1
|
위약
BI 474121
Ketamine hydrochloride
|
|
실험적: 치료 순서 R-T1-T2
|
위약
BI 474121
Ketamine hydrochloride
|
|
실험적: Treatment sequence R-T2-T1
|
위약
BI 474121
Ketamine hydrochloride
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Difference between the total number of errors adjusted for stages that subjects did not complete in the paired associate learning test (PALTEA28), post-ketamine minus the PALTEA28 pre-ketamine
기간: up to 22 days
|
up to 22 days
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Difference between the between errors in the spatial working memory test (SWMBE468), post-ketamine minus the SWMBE468 pre-ketamine
기간: up to 22 days
|
up to 22 days
|
|
Difference between the Rapid Visual Information Processing test A' (RVPA), post-ketamine minus the RVPA pre-ketamine
기간: up to 22 days
|
up to 22 days
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1411-0003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.mystudywindow.com/msw/datatransparency
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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