Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
研究概览
简要总结
This study is known as a "drug interaction study." The purpose is to learn how commonly used drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and their breakdown products get into the bloodstream after taking a "cocktail" (combination) of them before and after multiple doses of mirikizumab.
The study will last about 23 weeks for each participant. Screening must be completed within 4 weeks prior to study start.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
- •Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site
排除标准
- •Pregnant or nursing (lactating)
- •History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
- •Have major surgery within 8 weeks prior to first admission to the clinical site or during the study
- •Have a history of lymphoma, leukemia, or any malignancy
- •Require treatment with the cocktail drugs within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
- •Have participated in any other study with mirikizumab
研究组 & 干预措施
Drug Cocktail
Period 1:
Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally
干预措施: Drug Cocktail (Drug)
Mirikizumab + Drug Cocktail
Period 2:
Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113)
Period 2:
Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116.
干预措施: Drug Cocktail (Drug)
Mirikizumab + Drug Cocktail
Period 2:
Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113)
Period 2:
Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours; post-dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
PK: Cmax of Warfarin
时间窗: Period 1: Day 1: predose,1,2, 4,6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose,1,2,4,6,8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours, Day 120: 96 hours;post-dose
PK: Cmax of Warfarin
PK: Cmax of Dextromethorphan
时间窗: Period 1: Day 1: predose, 1, 2, 4, 6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose
PK: Cmax of Dextromethorphan
PK: Cmax of Omeprazole
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: Cmax of Omeprazole
PK: Cmax of Caffeine
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: Cmax of Caffeine
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours;post-dose
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
时间窗: Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose, 1, 2, 4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours,Day 119: 72 hours,Day 120: 96 hours;post-dose
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Warfarin
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
时间窗: Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Dextromethorphan
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Omeprazole
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
时间窗: Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Caffeine
次要结局
未报告次要终点