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

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

To investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects. In addition, in 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.

Inclusion Criteria:

Healthy adult part

1. Japanese healthy adult male subjects
2. Age at the time of informed consent: 18 to 45
3. BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m^2

Chronic kidney disease patient part

1. Chronic kidney disease patients with type 2 diabetes mellitus
2. Age at the time of informed consent: 18 to less than 65
3. UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g

Exclusion Criteria:

Healthy adult part

1. 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.
2. Presence or history of severe allergy to drugs or food
3. Presence or history of drug or alcohol dependence

Chronic kidney disease patient part

1. Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease
2. Patients with type 1 diabetes mellitus
3. Patients with a history of dialysis treatment