Actively Recruiting
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
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-06-08
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese healthy adult male subjects
- Age between 18 and 45 years for healthy adults
- Body mass index (BMI) between 18.5 kg/m2 and less than 25.0 kg/m2 for healthy adults
- Chronic kidney disease patients with type 2 diabetes mellitus
- Age between 18 and less than 65 years for chronic kidney disease patients
- Urinary albumin-to-creatinine ratio (UACR) between 300 mg/g and less than 3500 mg/g for chronic kidney disease patients
You will not qualify if you...
- Current or past treatment for diseases affecting respiratory, cardiovascular, psychiatric, nervous, gastrointestinal, immune, liver, kidney, hematopoietic, or endocrine systems for healthy adults
- History of severe allergy to drugs or food for healthy adults
- History of drug or alcohol dependence for healthy adults
- Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease for chronic kidney disease patients
- Diagnosis of type 1 diabetes mellitus for chronic kidney disease patients
- History of dialysis treatment for chronic kidney disease patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days for healthy volunteers receiving single dose; up to 23 days for healthy volunteers receiving multiple doses; up to 74 days for chronic kidney disease patients receiving single or multiple doses
Participants receive single or multiple oral doses of ONO-3310 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
1 to several visits depending on dosing schedule and cohort
Duration - Up to 74 days depending on participant group
Participants are monitored for safety and pharmacodynamics outcomes after dosing.
Several post-treatment visits depending on cohort
Trial Site Locations
Total: 1 location
1
Souseikai Hakata Clinic
Fukuoka, Fukuoka, Japan
Actively Recruiting
Research Team
O
Ono Pharmaceutical Co., Ltd.
I
International Clinical Trial Support Desk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here