JPRN-jRCT2080222636未知1 期
Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects
适应症
试验速览
- 阶段
- 1 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination
- •- Have a body mass index (BMI) of 18.5 to 29.9 kg/m2
- •- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •- Have an abnormal blood pressure as determined by the investigator
- •- 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
- •- Are women who are pregnant or lactating
- •- Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study.
- •- Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening.
- •- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
- •- Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions
- •- Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
- •- Have an absolute neutrophil count (ANC) less than 2000 cells/micro
研究者
相似试验
已完成
1 期
A Study of Baricitinib in Healthy Japanese ParticipantsHealthy ParticipantsNCT02263911Eli Lilly and Company16
已完成
1 期
A Study to Measure Baricitinib (LY3009104) Absorption in Healthy ParticipantsHealthy VolunteersNCT02340104Eli Lilly and Company8
已完成
1 期
A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult ParticipantsHealthy VolunteersNCT04898101Acerta Pharma BV14
未知
2 期
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHHJPRN-jRCT2080223304Eli Lilly Japan K.K.
已完成
1 期
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy ParticipantsHealthy VolunteersNCT05303220Bristol-Myers Squibb56