NCT04697511已完成1 期
A Phase I, Single-Sequence, Open-Label, Single- and Multiple-Dose Study of the Effect of Evobrutinib on Midazolam Pharmacokinetics in Healthy Participants
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam
研究概览
简要总结
The study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- •Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
- •Participants have a body weight within 50.0 and 100.0 kilograms [kg] (inclusive) and body mass index within the range of 19.0 and 30.0 kilograms per square meter [kg/m^2] (inclusive)
- •Other protocol defined inclusion criteria could apply
排除标准
- •History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
- •Individuals with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study
- •Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening
- •History of any malignancy
- •History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
- •History of shingles within 12 months prior to Screening
- •History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
- •History of alcoholism or drug abuse within 2 years prior to Screening, or positive for drugs of abuse, nicotine/cotinine or alcohol by the laboratory assays conducted during Screening and Day -1
- •History of residential exposure to tuberculosis, or a positive QuantiFERON® test within 4 weeks prior to or at the time of Screening
- •Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening
- •Moderate or strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A4/5) within 4 weeks prior to the first administration of study intervention
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Midazolam and/or M2951
Experimental
干预措施: Midazolam (Drug)
Midazolam and/or M2951
Experimental
干预措施: M2951 (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam
时间窗: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Maximum Observed Plasma Concentration (Cmax) of Midazolam
时间窗: Pre-dose through 24 hours postdose on Days 1, 3 and 13
次要结局
- Maximum Observed Plasma Concentration (Cmax) of 1-hydroxymidazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Time to Reach Maximum Plasma Concentration (tmax) of Midazolam and 1-hydroxymidazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Apparent Terminal Half-life (t1/2) of Midazolam and 1-hydroxymidazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Midazolam and 1-hydroxymidazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Apparent Total Body Clearance (CL/F) of Midazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Apparent Volume of Distribution (Vz/F) of Midazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Up to Day 14)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity(Up to Day 14)
- Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings(Up to Day 14)
- Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of 1-hydroxymidazolam(Pre-dose through 24 hours postdose on Days 1, 3 and 13)
研究者
研究点 (1)
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