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A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus

NCT07619157

RecruitingPhase 1

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Type2 Diabetes Mellitus, Chronic Kidney Disease

Interventions: ONO-3310, Placebo, ONO-3310, Placebo, ONO-3310

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Fukuoka, Fukuoka, Japan