A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
2021년 6월 16일 업데이트: UCB Biopharma S.P.R.L.
An Open-Label, Parallel Group, Single-Center Study to Investigate the Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in CYP2C19 Genotyped Healthy Male Japanese Study Participants
The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.
연구 개요
연구 유형
중재적
등록 (실제)
39
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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Tokyo, 일본
- Up0083 001
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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
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
- The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
- The study participant has a body weight ≥50 kg and body mass index within the range [18 to 30] kg/m^2 (inclusive)
- The study participant is male
Exclusion Criteria:
- The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
- The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
- The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)
- The study participant has bilirubin >1.0 x ULN (isolated bilirubin >1.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %)
- The study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities
- The study participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
- The study participant has made a blood or plasma donation or has had a comparable blood loss (>450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Extensive metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
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Padsevonil은 사전 정의된 용량으로 투여됩니다.
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실험적: Intermediate metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
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Padsevonil은 사전 정의된 용량으로 투여됩니다.
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실험적: Poor metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
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Padsevonil은 사전 정의된 용량으로 투여됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
기간: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
기간: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
기간: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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AUC is the area under the plasma concentration-time curve from time zero to infinity.
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Terminal Half-life (t1/2) of a Single Dose Padsevonil
기간: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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The t1/2 is the apparent terminal half-life.
Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e.
non-calculated and non-flagged).
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
기간: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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The tmax is the time to reach maximum plasma concentration.
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
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Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
기간: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.
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Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
기간: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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AUCtau is the area under the plasma concentration time curve over a dosing interval.
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Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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Terminal Half-life (t1/2) of Multiple Doses Padsevonil
기간: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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The t1/2 is the apparent terminal half-life.
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Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
기간: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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The tmax, ss is the time of observed maximum plasma concentration at a steady-state.
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Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
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Percentage of Participants With Treatment Emergent Adverse Events During the Study
기간: From Baseline until the Safety Follow-up Visit (up to Day 21)
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An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device.
The event does not necessarily have a causal relationship with that treatment or usage.
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From Baseline until the Safety Follow-up Visit (up to Day 21)
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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 (실제)
2019년 9월 30일
기본 완료 (실제)
2019년 12월 27일
연구 완료 (실제)
2019년 12월 27일
연구 등록 날짜
최초 제출
2019년 8월 29일
QC 기준을 충족하는 최초 제출
2019년 8월 29일
처음 게시됨 (실제)
2019년 8월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 16일
마지막으로 확인됨
2021년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- UP0083
- JapicCTI-194958 (레지스트리 식별자: JapicCTI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified.
For this reason, data from this trial cannot be shared.
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. .