NCT05154136已完成1 期
A Phase 1, Open-Label, 2-period Drug-Drug Interaction Study to Investigate the Effect of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetic Profile of AB928 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Etrumadenant Administered With or Without Itraconazole
研究概览
简要总结
This study will evaluate the effect of multiple oral doses of itraconazole, on the pharmacokinetics of etrumadenant when etrumadenant is administered as a single dose in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female (of non-childbearing potential), at the screening visit
- •Body mass index between 18 and 32 kilograms/m^2 inclusive, at screening
- •Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
- •Clinical laboratory test results clinically acceptable at screening and check-in
- •Non-smokers or ex-smokers (must have ceased smoking and stopped using nicotine containing products >3 months prior to the first dosing) based on participant self-reporting
排除标准
- •Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, rheumatological, endocrine, connective tissue diseases or disorders
- •Have a clinically relevant surgical history in the opinion of the principal investigator or designee
- •Have a history of relevant atopy or hypersensitivity to the study drugs or related compounds (e.g., allergy to itraconazole or other azole antifungals
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- •Note: This is not an exhaustive list of criterias.
研究组 & 干预措施
Etrumadenant then Etrumadenant + Itraconazole
Experimental
Participants will receive the Treatment A (etrumadenant) followed by Treatment B (etrumadenant + itraconazole).
A washout period of 5 days will be maintained between the two treatments.
干预措施: Etrumadenant (Drug)
Etrumadenant then Etrumadenant + Itraconazole
Experimental
Participants will receive the Treatment A (etrumadenant) followed by Treatment B (etrumadenant + itraconazole).
A washout period of 5 days will be maintained between the two treatments.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Etrumadenant Administered With or Without Itraconazole
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant Administered With or Without Itraconazole
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant Administered With or Without Itraconazole
时间窗: Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
次要结局
- Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Apparent Total Plasma Clearance (CL/F) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Time to Cmax (Tmax) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Apparent First-order Terminal Elimination Rate Constant (Kel) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Apparent First Order Terminal Elimination Half-life (t1/2) of Etrumadenant Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Cmax of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- AUC(0-t) of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- AUC(0-inf) of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- AUC%extrap of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- CL/F of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Tmax of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Kel of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- t1/2 of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Vz/F of Etrumadenant Metabolites When Etrumadenant is Administered With or Without Itraconazole(Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2)
- Number of Participants with Treatment Emergent Adverse Events(Up to 30 days)
研究者
研究点 (1)
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