A Phase I, 14 Day, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Repeat Dose, Ascending Cohort Study to Evaluate the Safety, Tolerability Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse event (AE)
研究概览
简要总结
The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- •Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
- •Male or Female of non-childbearing potential.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions
排除标准
- •ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >
- •ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Estimated Glomerular Filtration Rate <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2)
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •History of Gastroesophageal reflux disease (GERD), dyspepsia, GI bleeding, GI surgery that could affect motility
研究组 & 干预措施
10 mg of GSK3179106 QD-Cohort 1
Eligible six subjects will receive 10 mg oral dose once daily for 14 days
干预措施: GSK3179106 (Drug)
50 mg of GSK3179106 QD-Cohort 2
Eligible six subjects will receive 50 mg oral dose once daily for 14 days
干预措施: GSK3179106 (Drug)
200 mg of GSK3179106 QD-Cohort 3
Eligible six subjects will receive 200 mg oral dose once daily for 14 days
干预措施: GSK3179106 (Drug)
400 mg of GSK3179106 QD-Cohort 4
Eligible six subjects will receive 400 mg oral dose once daily for 14 days
干预措施: GSK3179106 (Drug)
25 mg of GSK3179106 BID-Cohort 5
Eligible six subjects will receive 25 mg oral dose twice daily for 14 days
干预措施: GSK3179106 (Drug)
200 mg of GSK3179106 BID-Cohort 6
Eligible six subjects will receive 200 mg oral dose twice daily for 14 days
干预措施: GSK3179106 (Drug)
Matching placebo QD-Cohort 1, 2, 3, 4
Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days
干预措施: Matched Placebo (Drug)
Matching placebo BID-Cohort 5, 6
Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days
干预措施: Matched Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse event (AE)
时间窗: Up to Day 25
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
次要结局
未报告次要终点