The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Atrogi AB
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.
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
- Double (Participant, Investigator)
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
- •Provision of informed consent
- •Body mass index ≥ 18.5 and ≤ 30.0
- •Medically healthy participant
- •Willing to use of double barrier contraceptive method if of childbearing potential
排除标准
- •History or clinical manifestation of any clinically significant disease
- •History of dysphagia or any other swallowing disorder
- •Current smokers or users of nicotine products
- •History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol
研究组 & 干预措施
Arm 1
Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.
干预措施: ATR-258 Oral capsule (Drug)
Arm 2
Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.
干预措施: ATR-258 Oral solution (Drug)
Arm 1
Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between.
干预措施: ATR-258 Oral solution (Drug)
Arm 2
Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between.
干预措施: ATR-258 Oral capsule (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 48 hours
Peak Plasma Concentration (Cmax)
时间窗: 48 hours
次要结局
- Half life in plasma (T1/2)(48 hours)
- Time to maximum plasma concentration (Tmax)(48 hours)
- Adverse events(7 days post last dose)
- Apparent total body clearance following extravascular administration (CL/F)(48 hours)
- Volume of distribution following extravascular administration (Vz/F)(48 hours)