NCT07358858尚未招募1 期
A Randomized, Open-label, Two-period, Crossover Food Effect Study of QLS1410 in Healthy Chinese Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.
详细描述
All the qualified participants will be randomized (1:1) to two treatment sequences (fed/fasting and fasting/fed). In each period, participants will receive a single dosing of QLS1410 tablets either with or without a high-fat breakfast. There will be a one-week washout period in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
- •Males and females aged 18 to 55 years, inclusive.
- •Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m^2, inclusive, at screening.
- •Has a mean seated office systolic blood pressure (SBP) 110~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
- •QTcF (QT corrected using Fridericia's formula) <450 ms for males and <470 ms for females.
- •Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.
排除标准
- •Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.
- •Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
- •Use of systemic corticosteroids within 3 months prior to screening.
- •Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
- •Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.
- •Mean pulse >100 or <50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
- •Any of the following laboratory abnormalities at screening: ALT or AST >1.5 x upper limit of normal (ULN); Total bilirubin >1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine >ULN or eGFR <90 mL/min/1.73 m²; Serum potassium >ULN or sodium <135 mmol/L.
- •Smoking >5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
- •Alcohol consumption >14 units/week (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% wine) within 6 months before screening, or has a positive breath alcohol test at screening.
- •Blood donation >400 mL within 3 months or >200 mL within 4 weeks before screening, or plan to donate blood during the study.
- •Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
- •Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.
- •Pregnant/lactating females or positive pregnancy test at screening.
- •Inability to tolerate a high-fat meal.
研究者
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