A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Apparent terminal elimination rate constant (Kel)
研究概览
简要总结
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent
- •Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
- •Normal BMI (18 to ≤ 35 kg/m2)
- •Have a negative urine drug screen/alcohol breath test on admission to clinic
- •Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
- •Be in general good health
- •Clinical laboratory values within normal range
排除标准
- •Recent wound, or presence of an ongoing non-healing skin wound
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
- •History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
- •Blood donation or significant blood loss within 30 days prior to the first study drug administration
- •Plasma donation within 7 days prior to the first study drug administration
- •Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
- •Females who are pregnant or lactating
- •Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
- •Failure to satisfy the PI of fitness to participate for any other reason
- •Active infection or history of recurrent infections
- •Active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
- •Antibiotic treatment within 3 months
- •Chronic medical condition
- •Any acute illness within 30 days prior
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Tablet vs Capsule Formulation
Single oral dose of BLD-2660 capsule or tablet formulation
干预措施: BLD-2660 (Drug)
Dose Proportionality
Single oral dose of BLD-2660 tablet formulation
干预措施: BLD-2660 (Drug)
结局指标
主要结局
Apparent terminal elimination rate constant (Kel)
时间窗: Up to 40 days
Measured by plasma concentration
Time of the maximum drug concentration (Tmax)
时间窗: Up to 40 days
Measured by plasma concentration
Apparent terminal half-life (t½)
时间窗: Up to 40 days
Measured by plasma concentration
AUC from time 0 to infinity (AUC0-inf)
时间窗: Up to 40 days
Measured by plasma concentration
Maximum observed drug concentration (Cmax)
时间窗: Up to 40 days
Measured by plasma concentration
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
时间窗: Up to 40 days
Measured by plasma concentration
次要结局
- Incidence of adverse events (AEs)(Up to 40 days)