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

NCT07619157 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-08

No results posted yet for this study

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

Conditions

Interventions

DRUG

ONO-3310

Single oral dose of ONO-3310 to HV

DRUG

Placebo

Single oral dose of Placebo to HV

DRUG

ONO-3310

Multiple oral dose of ONO-3310 to HV

DRUG

Placebo

Multiple oral dose of Placebo to HV

DRUG

ONO-3310

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

Sponsors & Collaborators

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619157 on ClinicalTrials.gov