A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729
An Open-Label Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Dose of a New Tablet Formulation of TRTL-729 in Healthy Adults
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Tortugas Neuroscience Clinical Trials Coordinator
- 전화번호: 508-834-6470
- 이메일: clinicaltrials@tortugasneuro.com
연구 장소
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Auckland, 뉴질랜드
- 모병
- Clinical Trial Site
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
- Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.
- Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg/m^2 and body weight greater than (>)50 kilograms (kg).
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.
- QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
- Nonsmokers or light smokers (less than [<]10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.
- Females must be of nonchildbearing potential or, if of childbearing potential, must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.
- Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.
Exclusion Criteria:
- Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
- History of seizures, epilepsy, significant head injury associated with loss of consciousness, family history of seizures or epilepsy, or other conditions or medications that increase seizure risk.
- Clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, clinically significant ECG abnormalities, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.
- Active infection or clinically significant recent illness before screening or dosing.
- Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
- Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
- History of malignancy within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).
- Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.
- Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior
- Pregnant, breastfeeding, or planning pregnancy during the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: TRTL-729
Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally. |
Participants will receive TRTL-729 tablets. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
기간: Up to Day 10
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Up to Day 10
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
기간: Up to Day 10
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Up to Day 10
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Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
기간: Up to Day 10
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Up to Day 10
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2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Plasma Concentrations of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Maximum Observed Plasma Concentration (Cmax) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Time to Maximum Plasma Concentration (Tmax) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729
기간: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 729-CLP-101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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