An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
研究概览
简要总结
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.
- •For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).
排除标准
- •History of cancer (malignancy).
- •Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- •Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
- •Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.
- •Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
研究组 & 干预措施
Efinopegdutide in Participants with Moderate Hepatic Impairment
Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
干预措施: Efinopegdutide (Drug)
Efinopegdutide in Participants with Severe Hepatic Impairment
Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
干预措施: Efinopegdutide (Drug)
Efinopegdutide in Healthy-Matched Control Group
Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
干预措施: Efinopegdutide (Drug)
结局指标
主要结局
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.
Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.
Maximum Plasma Concentration (Cmax) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.
Time to Maximum Concentration (Tmax) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.
Apparent Terminal Half-life (t/12) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.
Apparent Total Clearance (CL/F) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.
Apparent Volume of Distribution (Vz/F) of Efinopegdutide
时间窗: At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35
Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.
次要结局
- Number of Participants Who Experienced an Adverse Event (AE)(Up to 35 days)
- Number of Participants Who Discontinued Study Intervention Due to an AE(Up to 35 days)