A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Clinically Significant Event(s)
研究概览
简要总结
The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
- •Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- •Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
排除标准
- •Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
- •Have an abnormality in the 12-lead electrocardiogram (ECG).
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- •Have a history of stomach or intestinal surgery.
- •Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
- •Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]).
- •Have current herpes zoster or simplex within 90 days prior to the first dose,
- •Have evidence of active or latent tuberculosis (TB)
- •Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
- •Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
研究组 & 干预措施
2 milligram (mg) Baricitinib
2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
干预措施: Baricitinib (Drug)
4mg Baricitinib
4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
干预措施: Baricitinib (Drug)
10mg Baricitinib
10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
干预措施: Baricitinib (Drug)
Placebo
Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With One or More Clinically Significant Event(s)
时间窗: Baseline through Study Completion (up to Day 20)
Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
次要结局
- Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib(Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose)
- Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib(Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose)