A Phase 1 Open-label, Randomised, Crossover Study to Assess the Effect of Food on the Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve
研究概览
简要总结
The goal of this clinical trial is to Assess the Effect of Food on the
Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants. The main question[s] it aims to answer are:
- Evaluate the PK of D3S-001 administered in the fasted and fed state in healthy adult participants.
- Evaluate the safety and tolerability of D3S-001 administered in the fasted and fed state in healthy adult participants.
Potential participants will be screened within 28 days prior to the first dose. Participants will be admitted into the clinical research unit (CRU) on Day -1 and will be confined until end of study (EOS) or until early termination. On Day 1, participants will be randomised to Group 1 or Group 2. Participants will receive Treatment A or Treatment B in each of 2 periods (Periods 1 and 2; Study Days 1 and 4), once under fasted conditions (Treatment A) and once under fed conditions (Treatment B). Each participant will receive both treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- •Males or females of any race, aged between 18 to 65 years, inclusive, with a body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- •History of stomach or intestinal surgery (including but not limited to cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- •Unable or unwilling to consume the protocol-specified high-fat breakfast.
- •Other protocol inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1 - Fasted and Fed
Period 1 (day 1-3): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours.
Period 2 (day 4 to 6): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.
干预措施: D3S-001 (Drug)
Group 2 - Fed and Fasted
Period 1 (day 1-3): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.
Period 2 (day 4-6): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours.
干预措施: D3S-001 (Drug)
结局指标
主要结局
Area under the concentration-time curve
时间窗: From screening to end of treatment at 34 days
Evaluate the area under the concentration-time curve from time zero to the time of the last quantifiable concentration after D3S-001 administered in the fasted and fed state.
Maximum Observed Concentration (Cmax)
时间窗: From screening to end of treatment at 34 days
Maximum Observed Concentration (Cmax) of D3S-001 administered in the fasted and fed state.
次要结局
- Adverse events(From screening to end of study (approximately 34 days))
- Number of clinically significant clinical laboratory findings(On Screening visit, Day -1, Days 2-3 and Days 5-6 (End of Study))
- Number of clinically significant physical examinations(On Screening visit, Day -1 and Day 6 (End of Study))
- Number of clinically significant electrocardiogram parameters(On screening day, Day -1 and Days 1-6 (End of Study))
- To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.(On screening day, Day -1 and Days 1-6 (End of Study))