Testing ONO-3310 in healthy men and in adults with kidney disease and diabetes
Tests ONO-3310 in healthy men and in people with type 2 diabetes and kidney disease.
Plain-language title generated from the registry record
Registry title: A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Key facts
- Where
- Fukuoka, JapanSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07619157, who can take part
Where in Japan
- Souseikai Hakata ClinicFukuoka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT07619157
- Record updated
- 8 June 2026
- Original description
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 mellitusRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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; Healthy adult part.