A Single-dose, Randomized, 3-period, Crossover Study to Evaluate the Relative Bioavailability of BCX4161 Formulated as a Soft Gelatin Capsule to BCX4161 Formulated as a Hard Gelatin Capsule and the Effect of Food on BCX4161 Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules
研究概览
简要总结
The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg
- •Abide by study restrictions
- •Attend all study visits
- •Acceptable birth control measures
排除标准
- •Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
- •Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits
- •Pregnant or nursing
- •Recent history of alcohol abuse or positive drugs of abuse screen
- •Current smokers
- •Donation or loss of greater than 400 mL of blood within 3 months
研究组 & 干预措施
Treatment A
BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1
干预措施: BCX4161 (Drug)
Treatment B
BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1
干预措施: BCX4161 (Drug)
Treatment C
BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1
干预措施: BCX4161 (Drug)
结局指标
主要结局
Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules
时间窗: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling
次要结局
- Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations(Screening through study completion (approximately 61 days))
- Plasma pharmacokinetics to assess the effect of food on BCX4161(Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling)