Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
研究概览
简要总结
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
详细描述
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Sex: male and female participants.
- •Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
- •Additional Inclusion Criteria for Participants with Normal Hepatic Function
- •Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
- •Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
- •Additional Inclusion Criteria for Participants with Hepatic Impairment
- •Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- •Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
- •Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.
排除标准
- •All participants:
- •Known or suspected hypersensitivity to the IMP or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
结局指标
主要结局
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
时间窗: Day 1 (pre-dose) to Day 50 (Follow-up)
次要结局
- AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide(Day 1 (pre-dose) to Day 50 (Follow-up))
- Maximum Observed Plasma Concentration (Cmax) of Petrelintide(Day 1 (pre-dose) to Day 50 (Follow-up))
- Time to Cmax (tmax)(Day 1 (pre-dose) to Day 50 (Follow-up))
- Apparent Clearance (CL/F) of Petrelintide(Day 1 (pre-dose) to Day 50 (Follow-up))
- Terminal Elimination Half-life (t1/2) of Petrelintide(Day 1 (pre-dose) to Day 50 (Follow-up))
- Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide(Day 1 (pre-dose) to Day 50 (Follow-up))
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Day 1 up to Day 50)