A Study of Tersolisib (LY4064809) in Participants With Kidney Impairment Compared With Participants With Normal Kidney Function

A vizsgálat adatai

Ki végzi

Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Azonosító

NCT07924930

A regiszteradat frissítve

2026. november 9.

Eredeti leírás

The main purpose of this study is to measure how much tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated.A teljes eredeti leírásKevesebb

A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Tersolisib in Participants With Renal Impairment Compared With Participants With Normal Renal Function

The main purpose of this study is to measure how much tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated.

For each participant, the study will last about 7 weeks including a 14-night stay in the clinical research unit (CRU) and one follow-up telephone call.

Bevonási feltételek: Have a body mass index (BMI) within the range 19 to 42 kilograms per square meter (kg/m²), inclusive; Participants assigned male at birth (AMAB) who agree to follow contraception guidance or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP); Participants with Normal Renal Function:; Are healthy with normal renal function, defined as estimated glomerular filtration rate (eGFR) greater than or equal to 90 milliliters per minute (mL/min) at screening; Participants with Renal Impairment:; Have moderate renal impairment, defined as eGFR greater than or equal to 30 and less than 60 mL/min, or severe renal impairment, defined as eGFR less than 30 mL/min and not requiring dialysis; Are on stable doses of prescription or over-the-counter medications for the management of chronic kidney disease; Have acceptable blood pressure as defined by systolic blood pressure less than 160 millimeters of mercury (mmHg) and diastolic blood pressure less than 95 mmHg, as well as acceptable pulse rate, defined as no less than 50 beats per minute (bpm) and no greater than 100 bpm.

Kizáró feltételek: Have a current, functional renal transplant; Have a clinically significant history of multiple or severe drug hypersensitivity reactions, or drug allergies, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine; Have a history of a major surgical procedure within 30 days prior to screening; Have been diagnosed with, or treated for, malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix; Have a history or presence of any of the following clinically significant conditions: metabolic, biliary, gastrointestinal, hematological, neurological diseases, active cardiovascular (CV) disease or history of myocardial infarction within 3 months of planned dose of tersolisib, or 12-lead electrocardiogram (ECG) abnormalities that are clinically significant at screening, admission or predose; Have evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 and HIV-2 antibodies; Have a current infection with Hepatitis C Virus (HCV), that is, positive for HCV Ribonucleic Acid (RNA); Have a current infection with Hepatitis B Virus (HBV), that is, positive test for Hepatitis B Surface Antigen (HBsAg) or polymerase chain reaction positive for HBV DNA; Have history of chronic liver disease, or any evidence for hepatic impairments, or; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times (x) upper limit normal (ULN) or; total bilirubin (TBL) greater than 1.5 x ULN.

ClinicalTrials.gov NCT07924930