A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Recruiting · NCT07619157 · Interventional (participants receive a specific treatment) · Lead sponsor: Ono Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ONO-3310Placebo
What this trial is about
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 take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Healthy adult part
- 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
Where it is running
2 locations listed.
- Souseikai Hakata Clinic - Fukuoka, Fukuoka, Japan
- Souseikai Hakata Clinic - Fukuoka, Fukuoka, Japan