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

Ono Pharmaceutical Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Chronic Kidney Disease; Type2 Diabetes Mellitus

Treatments: Drug: ONO-3310; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07619157

ONO-3310-01

jRCT2071260026 (Other Identifier)

Details and patient eligibility

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

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 5 patient groups, including a placebo group

Single-dose ONO-3310

Experimental group

Treatment:

Drug: ONO-3310

Drug: ONO-3310

Drug: ONO-3310

Single-dose placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Multiple-dose ONO-3310

Experimental group

Treatment:

Drug: ONO-3310

Drug: ONO-3310

Drug: ONO-3310

Multiple-dose placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Single- and multiple-dose ONO-3310

Experimental group

Treatment:

Drug: ONO-3310

Drug: ONO-3310

Drug: ONO-3310