Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
2014년 10월 16일 업데이트: Novo Nordisk A/S
Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects
This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.
Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.
Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.
연구 개요
상태
빼는
정황
연구 유형
중재적
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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- BMI greater than 27.0 and less than 35.0 kg/m2
Exclusion Criteria:
- Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
- Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
- Eating disorders
- Unusual diets or eating habits
- Dieting, use of diet drugs or obesity surgery
- Diabetes history or abnormal fasting glucose
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 |
|---|---|
|
실험적: 이자형
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
실험적: ㅏ
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
실험적: 비
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
실험적: 씨
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
실험적: 디
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
기간: Including screening and evaluation: after approx. 7 weeks
|
Including screening and evaluation: after approx. 7 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
AUC (area under the curve)
기간: 21 days following dosing
|
21 days following dosing
|
|
Maximum plasma concentration
기간: 21 days following dosing
|
21 days following dosing
|
|
Time to maximum plasma concentration
기간: 21 days following dosing
|
21 days following dosing
|
|
Half life
기간: 21 days following dosing
|
21 days following dosing
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
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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
2008년 7월 1일
기본 완료 (예상)
2009년 12월 1일
연구 완료 (예상)
2009년 12월 1일
연구 등록 날짜
최초 제출
2008년 7월 31일
QC 기준을 충족하는 최초 제출
2008년 7월 31일
처음 게시됨 (추정)
2008년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 10월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 10월 16일
마지막으로 확인됨
2014년 10월 1일
추가 정보
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. .