A Randomized, Open-Label, Single Dose, Cross-Over Study to Evaluate the Pharmacokinetics of Three QRL-101 Formulations in a Fasted Condition or in the Presence of a High Fat Meal in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Plasma PK profile (AUCinf)
研究概览
简要总结
This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
详细描述
This is a randomized, open-label, single-dose, crossover study to evaluate the PK of three formulations of QRL-101 beginning in a fasted condition before moving to a fed cross-over design. Approximately 24 healthy participants will be enrolled in a 3-formulation, 4-period, 6-sequence crossover study design to evaluate the PK characteristics of three formulations of QRL-101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
A participant and investigator-blinded, randomized, open-label, single-dose, cross-over design will be used to minimize bias in this study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 70 years of age inclusive at the time of signing the informed consent.
- •Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
- •Body mass index of 18 to 32 kg/m2 (inclusive).
- •Willing and able to practice effective contraception.
排除标准
- •Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Any participant in >4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
- •History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
研究组 & 干预措施
Treatment Sequence 1 (Formulation 1, 2, and 3)
Participants randomized to Treatment Sequence 1 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 2, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
Treatment Sequence 2 (Formulation 2, 3, and 1)
Participants randomized to Treatment Sequence 2 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 3, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
Treatment Sequence 3 (Formulation 3, 1, and 2)
Participants randomized to Treatment Sequence 3 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 1, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
Treatment Sequence 4 (Formulation 2, 1, and 3)
Participants randomized to Treatment Sequence 4 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 3, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
Treatment Sequence 5 (Formulation 2, 1, and 3)
Participants randomized to Treatment Sequence 5 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 1, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
Treatment Sequence 6 (Formulation 3, 2, and 1)
Participants randomized to Treatment Sequence 6 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 2, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
干预措施: QRL-101 (Drug)
结局指标
主要结局
Plasma PK profile (AUCinf)
时间窗: Baseline through Follow up (Day 9)
The area under the curve to infinity
Plasma PK profile (AUClast)
时间窗: Baseline through Follow up (Day 9)
The area under the curve to the last measurable time point
Plasma PK profile (Cmax)
时间窗: Baseline through Follow up (Day 9)
Maximum concentration observed
Plasma PK profile (Ctrough)
时间窗: Baseline through Follow up (Day 9)
Trough level concentration for defined dose regimen
Plasma PK profile (Tmax)
时间窗: Baseline through Follow up (Day 9)
The time to peak drug concentration
次要结局
- Safety and tolerability(Baseline through Follow up (Day 9))