NCT06719128已完成1 期
An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
研究概览
简要总结
The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of non-childbearing potential.
- •Men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²).
- •Able to comply with all study procedures, including the 5- to 6-night stays at the CRU and the follow-up phone call.
- •Healthy participants: In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee).
- •Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.
排除标准
- •Females who are lactating or of childbearing potential.
- •History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- •Metabolic disease
- •Gastrointestinal disease
- •Hematological disease
- •Neurological disease
- •History or presence of clinically significant cardiovascular disease.
- •Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
- •Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
- •Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
- •Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor.
- •History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
研究组 & 干预措施
Olomorasib (Mild Hepatic Impairment)
Experimental
Olomorasib administered orally.
干预措施: Olomorasib (Drug)
Olomorasib (Moderate Hepatic Impairment)
Experimental
Olomorasib administered orally.
干预措施: Olomorasib (Drug)
Olomorasib (Severe Hepatic Impairment)
Experimental
Olomorasib administered orally.
干预措施: Olomorasib (Drug)
Olomorasib (Normal Hepatic Function)
Experimental
Olomorasib administered orally.
干预措施: Olomorasib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
时间窗: Predose on Day 1 up to 96 hours postdose
PK: Cmax of Olomorasib
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib
时间窗: Predose on Day 1 up to 96 hours postdose
PK: AUC0-inf of Olomorasib
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric ParticipantsGram-negative Bacterial InfectionsHospital Acquired Bacterial Pneumonia (HABP)Complicated Urinary Tract Infection (cUTI)Ventilator Associated Bacterial Pneumonia (VABP)NCT04215991Shionogi91
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)Elevated Serum Lipoprotein(a)NCT04987320Amgen24
终止
3 期
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric SubjectsPost-Operative PainAcute PainNCT02687451Endo Pharmaceuticals28
Unknown
1 期
Scopolamine in Healthy VolunteersMajor Depressive Disorder (MDD)NCT03874130Repurposed Therapeutics, Inc.130
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal ImpairmentRenal ImpairmentNCT05489614Amgen33