A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type … (NCT07619157) | Clinical Trial Compass
RecruitingPhase 1
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Japan120 participantsStarted 2026-06-02
Plain-language 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
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Japanese healthy adult male subjects
. Age at the time of informed consent: 18 to 45
. BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m\^2
. Chronic kidney disease patients with type 2 diabetes mellitus
. Age at the time of informed consent: 18 to less than 65
. UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial testing ONO-3310 for the first time in people with chronic kidney disease and type 2 diabetes, what does that mean for how much is already known about its safety in someone with my health profile?
2The trial is measuring how the drug moves through the body — things like how quickly it's absorbed and cleared — so does that mean the main goal right now is understanding the drug's behavior rather than proving it actually improves my kidney disease or diabetes?
3One of the things being tracked is the urinary albumin-to-creatinine ratio, which is a marker of kidney health — is my current level stable enough that joining a first-in-patient study like this would be appropriate, or would standard treatments be a better priority for me right now?
4Because the study includes both healthy volunteers and patients with chronic kidney disease and type 2 diabetes, can you help me understand what risks might be specific to me given that my kidneys may already affect how drugs are processed in my body?
5What would happen to my existing diabetes and kidney disease management — like my current medications or monitoring schedule — if I were to participate in this trial, and could enrolling affect my access to standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse event
Timeframe: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)
2
Maximum plasma observed concentration (Cmax)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
3
Time to reach maximum observed concentration (Tmax)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
4
Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24h)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
5
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
6
Area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUClast)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
. Subjects who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function.
. Presence or history of severe allergy to drugs or food
. Presence or history of drug or alcohol dependence
. Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease
. Patients with type 1 diabetes mellitus
. Patients with a history of dialysis treatment
Elimination half-life (T1/2)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
8
Apparent total clearance (CL/F)
Timeframe: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
9
Urinary excretion rate of unchanged drug
Timeframe: Up to 6 days (HV single)
10
Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)