NCT07619157RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 May 2026
- Start date
- 2 Jun 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07619157
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 2 Jun 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Chronic kidney disease patient part
- 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
Other
- Healthy adult part
Who the study is looking for
- Healthy adult part
- 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 patient part
- 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
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Souseikai Hakata Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.