- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01030939
Study to Investigate Safety, Tolerability, Pharmacokinetics and Cardiac Function After Repeat Doses of SB-649868 in Healthy-volunteers
A Single-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate Safety, Tolerability, Pharmacokinetics and the Effects on Cardiac Function of Repeat Oral Doses of SB-649868 in Adult and Elderly Healthy Volunteers
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
-
Berlin, 독일, 14050
- GSK Investigational Site
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Healthy male or female subject as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However,
- Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment;
- Subjects with AST or ALT > 2xULN should always be excluded from enrollment;
- Subjects with alkaline phosphatase or bilirubin > 1.5xULN should always be excluded (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Age > or equal to 18 years (applied only to Cohort 1 and 2); age >65 years (applied only to Cohort 3 and 4);
- Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive. Slight deviations from these values will be discussed and approved by the Investigator and the GSK Medical Monitor to allow subject inclusion into the study
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their Hormone Replacement Therapy (HRT) during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of contraceptive methods
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for 6 weeks following discontinuation of study medication.
- Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTcB or QTcF < 450 msec; PQ 120-220ms; QRS <120ms; no significant rhythm disorders in SCR 24h Holter-ECG
Exclusion Criteria:
- History or presence of significant psychiatric, neurological, respiratory, gastrointestinal, hepatic, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of cardiovascular diseases and/or evidence of repolarization defects
History of regular alcohol consumption within 6 months of the study defined as:
• an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Vulnerable subjects , or subject is mentally or legally incapacitated, or language barrier precluding adequate understanding of cooperation.
- Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 in the last month on the C-SSRS administered at screening
- Pregnant females as determined by positive Serum beta-hCG test at screening or prior to dosing.
- Lactating females.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody.
- cTpn I values above of 99th percentile of the laboratory reference interval
- A positive pre-study drug/alcohol screen.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
- The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Cohort 1: SB-649868
Healthy adult male subjects
|
In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo
|
실험적: Cohort 2
Healthy adult female subjects
|
In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo
|
실험적: Cohort 3
Healthy male elderly subjects
|
In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo
|
실험적: Cohort 4
Healthy female elderly subjects
|
In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Safety and tolerability evaluated by adverse event monitoring, ECG, vital signs, physical examination, laboratory values (including cTpn I and Insulin) and Romberg/heel to toe test
기간: screening period of 28 days followed by 28 days plus a follow up during 2 weeks approximately
|
screening period of 28 days followed by 28 days plus a follow up during 2 weeks approximately
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
pharmacokinetic after repeat dose. Pharmacodynamic outcomes:Doppler evaluation for tissue velocities, Doppler evaluation of flow, End diastolic and systolic volume and ejection fraction, E/E', and HOMA
기간: within 28 days
|
within 28 days
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 112861
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
연구 데이터/문서
-
임상 연구 보고서
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
데이터 세트 사양
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
주석이 달린 사례 보고서 양식
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
정보에 입각한 동의서
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
연구 프로토콜
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
통계 분석 계획
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: 112861정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
SB-649868에 대한 임상 시험
-
Medica Cor Heart Hospital알려지지 않은
-
GlaxoSmithKline완전한