- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06591845
Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
연구 개요
상태
정황
상세 설명
This clinical study is a single-center, randomized, partially double-blind, placebo- and active-controlled, four-period crossover design, with healthy subjects comprising the enrolled population. Ziresovir and placebo will be administered in a double-blind manner, while moxifloxacin hydrochloride tablets will be administered in as open-label.
Thirty-two subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized into 1 of 12 dosing sequences, each consisting of 4 periods with an 8-day washout period in-between.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Glendale, California, 미국, 91206
- California Clinical Trials Medical Group, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- The subject voluntarily signed a written informed consent form.
- Male or female; between 18 and 50 years old (inclusive).
- Male subjects weighing ≥50 kg, female subjects weighing ≥45 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive), BMI= weight (kg)/height2 (m2).
- Healthy, as defined by no clinically significant or relevant abnormalities identified by vital signs, physical examination, laboratory examination items, ECG, and other trial-related examinations at screening, admission or baseline day of each period as assessed by the investigator.
- The subject can communicate well with the investigator and is able to complete the study in compliance with the protocol.
Exclusion Criteria:
- History of or evidence of clinically significant disorder, condition or disease not otherwise excluded that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History of cardiovascular disease or risk factors for Torsade de Pointes (TdP) at screening, including but not limited to: unexplained syncope; heart failure; cardiomyopathy; hypertension; angina pectoris; myocardial infarction; hypokalemia; bradycardia or sick sinus syndrome; cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death.
- Known or suspected malignancy.
- Known allergic reactions to study intervention (e.g., ziresovir or its drug excipients, moxifloxacin, fluoroquinolone antibiotics) or history of clinically significant multiple or severe drug allergies, food allergies.
- Subjects who have donated blood or have had a blood loss ≥500 ml within 3 months prior to screening.
- Subjects who have participated in a clinical trial evaluating an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
- History of substance abuse (e.g., alcohol, licit or illicit drugs) within 1 year prior to screening.
- 12-lead ECG at screening or admission exceeding criteria: PR>220 ms, QRS>120 ms, HR< 50 bpm or >100 bpm, QTcF >450 ms (male and female) (The mean of 3 triplicate ECGs timepoint measurement); or ECG abnormalities that are considered by the investigator to be abnormal and clinically significant.
- Systolic blood pressure (BP) > 140 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg at screening or admission.
- Serum potassium, calcium, or magnesium levels outside the normal range at screening or admission.
- Positive blood alcohol test, positive urine cotinine test or positive urine drug abuse screening at screening or admission.
- Engaged in strenuous exercise within 48 hours before randomization (e.g., marathon running, long-distance cycling, weightlifting).
- Intake of caffeinated beverages or food within 48 hours before randomization or a history of high caffeine consumption (e.g., in the last 3 months drinking >5 cups of coffee/day).
- History of alcoholism or regular alcohol consumption within 1 year prior to screening, defined as more than 14 units (male) or 7 units (female) of alcohol per week (1 unit =360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine).
- Smoking or use of tobacco or nicotine-containing products within 6 months before screening.
- Pregnant or lactating women or those with positive blood pregnancy test results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment T (Therapeutic dose)
The subjects will receive a ziresovir 125 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
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Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
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실험적: Treatment ST (Supratherapeutic dose)
The subjects will receive a ziresovir 500 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
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Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
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위약 비교기: Treatment P (Placebo)
The subjects will receive a placebo as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
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Active Substance: Placebo, Pharmaceutical Form: Suspension, Route of Administration: Oral
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활성 비교기: Treatment PC (positive control)
The subjects will receive a moxifloxacin hydrochloride tablet 400 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
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Active Substance: Moxifloxacin hydrochloride Pharmaceutical Form: Tablet Route of Administration: Oral
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline QTcF (ΔQTcF)
기간: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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The primary ECG endpoint is the change from baseline in the QT interval corrected for heart rate (HR) using the Fridericia method (ΔQTcF).
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Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in QTc
기간: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Change from baseline in QTc using correction methods not chosen as the primary correction method if a substantial HR effect is observed
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Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Change from baseline in HR, PR, and QRS
기간: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Change-from-baseline in HR, PR and QRS (ΔHR, ΔPR and ΔQRS).
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Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
기간: Up to Day 8 of each treatment period (up to 31 days)
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Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
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Up to Day 8 of each treatment period (up to 31 days)
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Treatment-emergent changes in ECG Morphology
기간: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Treatment-emergent changes in ECG Morphology
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Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Categorical outliers for QTcF/QTcI/QTcS, HR, PR, and QRS.
기간: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Categorical outliers for QTcF/QTcI/QTcS, HR, PR, and QRS.
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Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
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Maximum observed plasma concentration (Cmax) of ziresovir
기간: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period
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PK parameters of ziresovir and its metabolites including maximum observed plasma concentration (Cmax).
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Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period
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Terminal elimination half-life (t1/2) of ziresovir.
기간: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
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PK parameters of ziresovir and its metabolites including terminal elimination half-life (t1/2).
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Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
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Area under the curve (AUC) of ziresovir.
기간: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
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PK parameters of ziresovir and its metabolites including area under the curve (AUC).
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Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Han, M.D., M.P.H, California Clinical Trials Medical Group
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AK0529-3004
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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