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A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe

2014년 10월 21일 업데이트: Eli Lilly and Company

Comparative Pharmacokinetics of Dulaglutide After Administration Via an Auto-injector and a Manual Syringe in Healthy Subjects

The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled manual syringe, the other given by an auto-injector. Injections will be separated by a minimum 28-day washout period. The study will evaluate if the levels of drug in the blood are similar when given by each method. Participation in the study is likely to take approximately 7 weeks, not including screening.

연구 개요

상태

완전한

연구 유형

중재적

등록 (실제)

50

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Florida
      • Daytona Beach, Florida, 미국, 32117
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Male participants with female partners of child-bearing potential or partners who are pregnant or breastfeeding agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator
  • The method may be one of the following:

    • condom with spermicidal agent
    • male participant sterilization
    • true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)
  • Female participants not of child-bearing potential (that is, are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment
  • Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or spontaneous amenorrhea for 6 to 12 months, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliters (mIU/mL)
  • Female participants who have undergone sterilization by tubal ligation agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meters squared (kg/m^2), inclusive, at screening
  • Have clinical laboratory test results within the normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have venous access sufficient to allow for blood sampling as per the protocol
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

  • Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have known allergies to Glucagon-like peptide 1 (GLP-1) -related compounds including dulaglutide, or any components of the formulation
  • Are persons who have previously completed or withdrawn from this study or any other study investigating dulaglutide in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying (such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs. Participants with dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician
  • Show evidence of significant active neuropsychiatric disease
  • Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Are women with a positive pregnancy test or women who are lactating
  • Have used or intend to use over-the-counter medication other than acetaminophen within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy [HRT]) within 14 days prior to dosing
  • Have donated blood of more than 500 milliliters (mL) within the last month
  • Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to adhere to the alcohol restrictions (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Smoke more than 10 cigarettes (or equivalent in nicotine) per day, and are unwilling to refrain from smoking on the day of dulaglutide administration or are unable to abide by clinical research unit (CRU) restrictions
  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

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: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Manual syringe
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28-day minimum washout period.
Administered by subcutaneous (SC) injection
다른 이름들:
  • LY2189265
실험적: Auto-injector
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28-day washout period
Administered by subcutaneous (SC) injection
다른 이름들:
  • LY2189265

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
기간: Predose to 336 hours postdose
Predose to 336 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide
기간: Predose to 336 hours postdose
Predose to 336 hours postdose

2차 결과 측정

결과 측정
기간
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide
기간: Predose to 336 hours postdose
Predose to 336 hours postdose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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

2012년 3월 1일

기본 완료 (실제)

2012년 6월 1일

연구 완료 (실제)

2012년 6월 1일

연구 등록 날짜

최초 제출

2012년 1월 31일

QC 기준을 충족하는 최초 제출

2012년 1월 31일

처음 게시됨 (추정)

2012년 2월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 10월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 10월 21일

마지막으로 확인됨

2014년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 14142
  • H9X-MC-GBDT (기타 식별자: Eli Lilly and Company)

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. .

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