A Study of JNJ-70075200 in Healthy Participants
2021년 12월 14일 업데이트: Janssen Research & Development, LLC
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
연구 개요
연구 유형
중재적
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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Groningen, 네덜란드, 9728 NZ
- PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
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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:
- Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
- Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
- No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
- Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m^2) (BMI = weight/height^2) (inclusive)
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
Exclusion criteria:
- Participants having a history of liver or renal insufficiency (estimated creatinine clearance [CL] below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) for males, and >470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
- Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Part 1: Single Ascending Dose (SAD)
Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition.
Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.
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위약 용액은 구두로 투여됩니다.
JNJ-70075200 solution or solid formulations will be administered orally.
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실험적: Part 2: Multiple Ascending Dose (MAD)
After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.
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위약 용액은 구두로 투여됩니다.
JNJ-70075200 solution or solid formulations will be administered orally.
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실험적: Part 3: Single-dose Oral Solid Formulation (Optional)
Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition.
Part 3 will start after obtaining a formal regulatory/ethical approval.
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JNJ-70075200 solution or solid formulations will be administered orally.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
기간: Up to 1 year and 1 month
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Percentage of Participants with Serious Adverse Events (SAEs)
기간: Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Vital Signs
기간: Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Physical Examination
기간: Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Number of Participants With Clinically Significant Laboratory Abnormalities
기간: Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Change From Baseline in QTc Interval
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
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Baseline, up to 1 year and 1 month
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Change from Baseline in Heart Rate (HR)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in QRS Interval
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in PR Interval
기간: Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change From Baseline in QT Interval
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
기간: Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
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Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)
기간: Predose, up to 72 hours postdose (up to Day 4)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.
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Predose, up to 72 hours postdose (up to Day 4)
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Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)
기간: Up to 1 year and 1 month
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Part 1 and 3: Percentage of Participants with SAEs (Food Effect)
기간: Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)
기간: Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)
기간: Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)
기간: Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QTc interval using Fridericia method will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in HR (Food Effect)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)
기간: Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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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 (예상)
2022년 3월 1일
기본 완료 (예상)
2022년 5월 9일
연구 완료 (예상)
2022년 9월 23일
연구 등록 날짜
최초 제출
2021년 2월 16일
QC 기준을 충족하는 최초 제출
2021년 3월 3일
처음 게시됨 (실제)
2021년 3월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 1월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 12월 14일
마지막으로 확인됨
2021년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CR108971
- 2020-004946-12 (EudraCT 번호)
- 70075200SLE1001 (기타 식별자: Janssen Research & Development, LLC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
위약에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로