A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers
2014년 4월 7일 업데이트: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label Study to Assess the Effect of Multiple-Dose JNJ26489112 on the Cytochrome P450 Enzymes Using a 3-Probe Substrate Drug Combination in Healthy Subjects
The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics (blood levels) of a combination of 3 drugs administered to healthy volunteers.
연구 개요
상세 설명
26489112 is a drug that is being tested to see if it may be useful for a number of indications including major depression.
This study will compare the effects of 26489112 administered to healthy volunteers alone or in combination with a mixture of 3 drugs consisting of midazolam (a drug used for reducing anxiety or producing drowsiness or anesthesia before certain medical procedures or surgery), omeprazole (a drug used to treat symptoms of gastroesophageal reflux disease (GERD) or other conditions caused by excess stomach acid), and tolbutamide (a drug used for treating type 2 diabetes mellitus in patients when blood sugar cannot be controlled by diet and exercise alone).
Approximately 20 healthy adult volunteers will be enrolled and will be treated with study drug for 22 days.
Volunteers will be required to stay overnight at the study center to receive study treatment for 4 nights at the beginning of the study and for 4 nights towards the end of the study.
On all other occasions, volunteers will make daily visits to the study center to receive treatment with study drug.
Participants will take a combination of 3 drugs (omeprazole 20 mg capsule, tolbutamide 500 mg tablet, and midazolam 2mg/mL liquid) orally (by mouth) or 2 tablets of study drug (2648911) orally with 1 cup of water.
Blood samples will be collected from study participants at protocol-specified times during the study to determine the concentration of each of the 4 drugs (26489112, midazolam, omeprazole, and tolbutamide) present in plasma (the colorless fluid portion of blood).
In addition, a blood sample will be obtained from all enrolled patients before study drug administration for pharmacogenomics research (research to help identify genetic markers of response, to explain variability in the data, or to address emerging clinical issues).
The primary outcome measure is the concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters at protocol-specified time points on Days 1-4 and Dasy 19-22.
Safety will be monitored during the study.
Healthy volunteers will receive study drug (26489112) orally (by mouth) in the morning from Day 4 through Day 21.
연구 유형
중재적
등록 (실제)
20
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Merksem, 벨기에
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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
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study and must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
- If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy at least 6 months before study entry, double barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI
- weight [kg]/height [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic and results from a 12-lead electrocardiogram (ECG) that are consistent with normal cardiac conduction and function
- Nonsmoker for at least 6 months
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease including current suicidal ideation or behavior, infection, known history of G6PD deficiency, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Known clinically significant ophthalmologic examination results or known ocular deficits, including retinal disorders
- History of clinically significant allergies, known allergy to the study drug or any of the excipients of the formulation, or known allergy to heparin or history of heparin-induced thrombocytopenia
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 001
Drug combination/ 26489112 On Day 1 and on Day 19 a single oral dose of a drug combination consisting of midazolam (2 mg/mL liquid) tolbutamide (a 500 mg tablet) and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21 a single oral dose of two 26489112 tablets will be taken.
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On Day 1 and on Day 19, a single, oral dose of a drug combination consisting of midazolam (2 mg/mL liquid), tolbutamide (a 500 mg tablet), and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21, a single oral dose of two 26489112 tablets will be taken.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters
기간: Days 1-4 and Days 19-22
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Days 1-4 and Days 19-22
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2차 결과 측정
결과 측정 |
기간 |
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The number of patients with adverse events as a measure of safety.
기간: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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Results from clinical laboratory tests including blood glucose levels as a measure of safety.
기간: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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Findings from ECGs and vital sign measurements as a measure of safety.
기간: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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Findings from physical and neurologic examinations performed as a measure of safety.
기간: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
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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
2010년 6월 1일
연구 완료 (실제)
2010년 8월 1일
연구 등록 날짜
최초 제출
2010년 6월 17일
QC 기준을 충족하는 최초 제출
2010년 6월 17일
처음 게시됨 (추정)
2010년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 4월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 4월 7일
마지막으로 확인됨
2014년 4월 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. .
Drug combination/ 26489112에 대한 임상 시험
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Johnson & Johnson Pharmaceutical Research & Development...완전한
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