Phase 1 Study on Safety and Effects of ONO-3310 Oral Doses in Healthy Japanese Adult Males and Chronic Kidney Disease Patients with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and patients with chronic kidney disease who have type 2 diabetes mellitus. The study aims to understand how ONO-3310 behaves in the body and its effects in these two groups. This is a Phase 1 clinical trial sponsored by Ono Pharmaceutical Co., Ltd., focusing on early-stage testing. Participants include healthy Japanese adult males and adults with chronic kidney disease and type 2 diabetes. The study involves administering single and multiple oral doses of ONO-3310 or placebo. Healthy volunteers receive either single or multiple doses, while chronic kidney disease patients receive single or multiple doses of ONO-3310. The treatment periods vary, with monitoring lasting up to 10 days for single doses, 23 days for multiple doses in healthy volunteers, and 74 days for chronic kidney disease patients. During the study, participants will undergo safety and tolerability assessments, blood sampling to measure drug levels and pharmacokinetics, and evaluation of drug effects including urinary albumin-to-creatinine ratio in chronic kidney disease patients. Researchers will monitor adverse events and various pharmacokinetic parameters such as maximum plasma concentration, time to reach maximum concentration, and drug clearance. The study includes follow-up periods to track outcomes, with overall participation lasting up to about 74 days depending on the group.

A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus