A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Food Effect of BCI-838; and, An Open-Label Minidose Bioavailability Study to Compare Several BCI-632 Pro-drug Candidates in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.
详细描述
The first phase of this study will evaluate the safety and tolerability of BCI-838 following oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite following single oral doses of BCI-838 in healthy male subjects.
The second phase of this study will evaluate and compare the relative bioavailability and PK of the metabolite BCI-632 following single oral administration of several new pro-drug candidates in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adult male healthy volunteer, 18-55 years of age
- •Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
- •Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days
- •Able to participate and willing to give written informed consent and to comply with the study restrictions
排除标准
- •Clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder
- •History or current use of alcohol abuse or drug addiction
- •Participation in a drug study within 60 days prior to drug administration.
- •Participation in more than 3 other drug studies in the 10 months preceding the start of this study
- •Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study
- •Illness within 5 days prior to drug administration
研究组 & 干预措施
BCI-838 Food Effect Dosing Arm 1
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
干预措施: BCI-838 (Drug)
BCI-838 Fasted Dosing (100 & 300 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
干预措施: BCI-838 (Drug)
BCI-1038, BCI-1206 & BCI-1283
Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.
干预措施: BCI-1038, BCI-1206 & BCI-1283 (Drug)
BCI-838 Fasted Dosing (900 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
干预措施: BCI-838 (Drug)
结局指标
主要结局
Safety
时间窗: 7 days
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
次要结局
- Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632(predose and at specified intervals up to 72 hours post-dose)