NCT05175352已完成1 期
A Phase 1, Open-label, Single-sequence Study to Evaluate Potential Disease-mediated Drug-drug Interaction With Selected Cytochrome P450 Substrates in Adult Subjects With Active Eosinophilic Esophagitis Receiving Cendakimab
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
- Celgene
- 入组人数
- 16
- 试验地点
- 12
- 主要终点
- Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
研究概览
简要总结
The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Eosinophilic esophagitis (EoE) with histologic evidence as a peak count of ≥ 15 eosinophils per higher-power field at any 2 levels of the esophagus
- •Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE
- •EoE symptoms documented in daily diary during the screening period
排除标准
- •On a regimen of therapeutic anticoagulation
- •Demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
- •Currently receiving a high potency topical corticosteroid for dermatologic use
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Experimental
干预措施: Cendakimab (Drug)
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Experimental
干预措施: CYP substrates (Drug)
结局指标
主要结局
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
时间窗: Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
时间窗: Up to 18 Weeks
次要结局
- Pharmacokinetics - Maximum plasma concentration of drug (Cmax)(Up to 18 Weeks)
- Relationship of TEAEs(Up to 34 Weeks)
- Number of participants with clinical laboratory abnormalities(Up to 34 weeks)
- Number of participants with physical examination sign abnormalities(Up to 34 weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Up to 34 Weeks)
- Severity of TEAEs(Up to 34 Weeks)
- Number of participants with electrocardiogram abnormalities(Up to 34 weeks)
- Number of participants with vital sign abnormalities(Up to 34 weeks)
- Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time(Up to 34 Weeks)
研究者
研究点 (12)
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