A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Plasma PK parameter Cmax
研究概览
简要总结
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
详细描述
This is a single-dose, non-randomised, open-label, parallel-group study to examine the PK, fibroblast activation protein activity, safety, and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
The study is planned to consist of:
- Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)
- Cohort 2: Participants with mild hepatic impairment (CP A classification)
- Cohort 3: Participants with moderate hepatic impairment (CP B classification)
- Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
Safety, tolerability, and available plasma PK data up to 48 hours post-dose from at least 4 participants in each of the mild hepatic impairment (CP Class A) and moderate hepatic impairment (CP Class B) cohorts must have been assessed by the investigator(s), medical monitor, and sponsor prior to the decision to proceed with evaluation/recruitment of participants with severe hepatic impairment (CP Class C). Cohort 1 (normal hepatic function) will be initiated in parallel with Cohorts 2 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Hepatic:
- •Participant with a diagnosis of stable hepatic impairment
- •For Healthy:
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- •All participants:
- •- Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).
排除标准
- •Participant has eGFR < 60 mL/minute/1.73 m2
- •Positive test for HIV at screening
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
- •History of severe dermatological disorders
研究组 & 干预措施
Cohort 1
Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)
干预措施: AZD2389 (Drug)
Cohort 2
Participants with mild hepatic impairment (CP A classification)
干预措施: AZD2389 (Drug)
Cohort 3
Participants with moderate hepatic impairment (CP B classification)
干预措施: AZD2389 (Drug)
Cohort 4
Participants with severe hepatic impairment (CP C classification)
干预措施: AZD2389 (Drug)
结局指标
主要结局
Plasma PK parameter Cmax
时间窗: pre-dose to 48 hours post-dose
maximum observed plasma concentration
Plasma PK parameter AUCinf
时间窗: pre-dose to 48 hours post-dose
area under the concentration-time curve from zero to infinity
Plasma PK parameter AUClast
时间窗: pre-dose to 48 hours post-dose
area under the concentration-time curve from zero to the last measurable concentration
次要结局
- Plasma PK parameter t1/2λz(pre-dose to 48 hours post-dose)
- Urine PK parameter Ae(t1-t2)(pre-dose to 48 hours post-dose)
- Plasma PK parameter Tmax(pre-dose to 48 hours post-dose)
- Plasma PK parameter CL/F(pre-dose to 48 hours post-dose)
- Plasma PK parameter Vz/F(pre-dose to 48 hours post-dose)
- Urine PK parameter CLr(pre-dose to 48 hours post-dose)
- Urine PK parameters fe(t1-t2)(pre-dose to 48 hours post-dose)