A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of LOXO-292

Eli Lilly and Company6 个研究点分布在 1 个国家目标入组 37 人开始时间: 2018年12月19日最近更新: 2025年9月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 37
试验地点: 6
主要终点: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 9 days, excluding screening.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
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

•For all participants:
•Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
•Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
•Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening
•Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose
•For renal participants:
•Participant has stable renal disease status and function at least 1 month prior to LOXO-292 administration.
•Participant is not currently or has not previously being on hemodialysis
•Baseline estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows:
•Severe Renal Impairment (RI): < 30 milliliter per minute (mL/min)/1.73m²
•Moderate RI: ≥ 30 and < 60 mL/min/1.73m²
•Mild RI: ≥ 60 and < 90 mL/min/1.73m²
•The MDRD equation is as follows (for females multiply result by 0.742, if African American multiply result by 1.212):
•eGFR = 175 x [serum creatinine in milligrams per deciliter (mg/dL) measured with a standardized assay]^-1.154 x (Age)^-0.203

排除标准

•For renal participants:
•Has rapidly fluctuating renal function, as determined by historical measurements; or has demonstrated or suspected renal artery stenosis. Rapidly fluctuating renal function is defined as creatinine clearance or eGFR that differs by more than 20% within at least 3 months of the screening creatinine clearance or eGFR. If historical measurements are not available, then the 2 screening measurements will be used to demonstrate stability.
•Participants who have had a renal transplant, a nephrectomy, or participants with a known history of nephrotic syndrome.
•Participants who have required new medication for renal disease within 30 days prior to Check-in

研究组 & 干预措施

Selpercatinib (Control; Normal Renal Function)

Experimental

Participants with normal renal function (estimated glomerular filtration rate greater than or equal to [eGFR ≥ 90 milliliters per minute (mL/min) per 1.73 square meters (m²)] received a single 160 milligrams (mg) oral dose of Selpercatinib on Day 1, administered in a fasted state.

干预措施: Selpercatinib (Drug)

Selpercatinib (Mild Renal Impairment)

Experimental

Participants with mild renal impairment (eGFR between 60 and 90 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

干预措施: Selpercatinib (Drug)

Selpercatinib (Moderate Renal Impairment)

Experimental

Participants with moderate renal impairment (eGFR between 30 and 60 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

干预措施: Selpercatinib (Drug)

Selpercatinib (Severe Renal Impairment)

Experimental

Participants with severe renal impairment (eGFR less than (<) 30 mL/min/1.73 m² and not requiring hemodialysis) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

干预措施: Selpercatinib (Drug)

结局指标

主要结局

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma