A Study in Healthy Subjects Designed to Evaluate the Pharmacokinetic Profile of Firibastat (QGC001) and Active Metabolites Following Administration of Firibastat (QGC001) Prototype Tablet Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the time at which the Cmax is observed.
研究概览
简要总结
This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference Firibastat (QGC001) immediate release (IR) capsule formulation in healthy male subjects.
It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal product (IMP).
详细描述
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing and for each treatment period they will be admitted to the clinical unit on the evening prior to IMP administration (Day -1). On the morning of Day 1, subjects will receive IMP in the fasted state (or following a FDA standard high-fat breakfast, if applicable) and will remain on site until 48 h post-dose. Between the periods, an interim analysis and review of safety and PK data from dosed regimens will be performed in order to determine which Firibastat (QGC001) MR prototype tablet formulation and dose to administer in subsequent periods. A follow-up phone call will take place 7 to 10 days post-final dose to ensure the ongoing wellbeing of the subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18.0 to 32.0 kg/m2
- •Must adhere to the contraception requirements
排除标准
- •Subjects who have received any IMP in a clinical research study within the previous 3 months
- •Subjects with pregnant partners
- •History of any drug or alcohol abuse in the past 2 years
- •Clinically significant abnormal biochemistry, haematology or urinalysis
- •Subjects with BP <90/50 mmHg at screening
研究组 & 干预措施
Firibastat prototype tablet formulations
Firibastat (QGC001) 500 mg modified release prototype tablet formulations or immediate release capsule formulation - 1 tablet or 1 capsule administered per period
干预措施: Firibastat (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the time at which the Cmax is observed.
时间窗: 3 months
\[Tmax\]
Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Areas Under the Curve.
时间窗: 3 months
\[AUC0-24, AUC0-last and AUC0-inf\]
Pharmacokinetic (PK) profiles of Firibastat (QGC001) and active métabolites of modified release prototype tablet formulations. Assessment of the Maximum Plasma Concentration.
时间窗: 3 months
\[Cmax\]
次要结局
- Relative bioavailability of Firibastat (QGC001) modified release prototype tablet formulations compared to the immediate release capsule formulation(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing safety haematology and chemistry laboratory tests aggregated as number of patients outside normal ranges.(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing chemistry laboratory tests aggregated as number of patients outside normal ranges.(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing urinalysis aggregated as number of patients outside normal ranges.(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing vital signs(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing AEs(3 months)
- Safety and tolerability of single doses of Firibastat (QGC001) by assessing Twelve-lead ECGs(3 months)