RecruitingPhase 1NCT07619157

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

A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes mellitus


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ONO-3310, a drug called ONO-3310, and others for people with chronic kidney disease and type2 diabetes mellitus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONO-3310

Single oral dose of ONO-3310 to HV

DRUGPlacebo

Single oral dose of Placebo to HV

DRUGONO-3310

Multiple oral dose of ONO-3310 to HV

DRUGPlacebo

Multiple oral dose of Placebo to HV

DRUGONO-3310

Single or multiple oral dose of ONO-3310 to CKD patients


Locations(1)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, Japan

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NCT07619157


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