A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioKier Inc.
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Peak Plasma Concentration (Cmax) of butyrate
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.
详细描述
BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing. On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18-70 inclusive
- •Subjects currently on statin treatments.
排除标准
- •Presence of cirrhosis, or other causes of liver disease
- •Substantial alcohol consumption (>20 g/day for women or >30 g/day for men)
- •History of bariatric or intestinal surgery
- •Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis.
- •Active and clinically significant pancreatic disease, or renal disease as determined by the investigator.
- •History of heart disease that in the opinion of the investigator should exclude the subject from the study.
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- •Active significant infection as determined by the investigator.
- •Known allergy to butyrate or any of the components of the tablets.
- •Participation in a clinical trial and/or Dosing with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
- •Pregnant, nursing, or trying to become pregnant.
- •In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
- •Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
结局指标
主要结局
Peak Plasma Concentration (Cmax) of butyrate
时间窗: 8 days
Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing.
Area under the plasma concentration versus time curve (AUC)
时间窗: 8 days
AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma.
次要结局
- Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure(8 days)
- Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel(8 days)
- Incidence of Treatment-Emergent Adverse Events as assessed by heart rate(8 days)
- Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters(8 days)