A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUCinf
研究概览
简要总结
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
详细描述
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:
Group 1: Participants with severe renal impairment (eGFR < 30 mL/min), not on dialysis.
Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.
Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-80 years of age
- •Weight >50kg and BMI between 18-40 kg/m2
- •For participants with normal renal function:
- •Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.
- •For participants with renal impairment:
- •Group 1 (severe) must have an eGFR <30 ml/min and Group 3 (moderate) must have an eGFR 30 to <60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.
排除标准
- •Poorly controlled diabetes mellitus (A1C >10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
- •Unwillingness to use adequate contraception
- •Uncontrolled hypertension or hypotension.
- •Positive screening for HIV, Hepatitis B, or Hepatitis C
- •Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
- •Any change in baseline medication within 2 weeks of planned study initiation.
研究组 & 干预措施
Group 1
Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions.
干预措施: AZD5004 (Drug)
Group 2
Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions.
干预措施: AZD5004 (Drug)
Group 3 (Optional)
Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions.
干预措施: AZD5004 (Drug)
结局指标
主要结局
AUCinf
时间窗: Day 1 to Day 5
Area under the concentration-time curve from zero to infinity
AUClast
时间窗: Day 1 to Day 5
Area under the concentration-time curve from zero to the last measurable concentration
Cmax
时间窗: Day 1 to Day 5
Maximum observed plasma concentration
次要结局
- Tmax(Day 1 to Day 5)
- PK parameter t1/2λz(Day 1 to Day 5)
- PK parameter CL/F(Day 1 to Day 5)
- PK parameter CLNR/F(Day 1 to Day 5)
- PK parameter Vz/F(Day 1 to Day 5)
- PK parameter CLr(Day 1 to Day 5)
- PK parameter Ae(Day 1 to Day 5)
- fe(Day 1 to Day 5)