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

Phase 1RecruitingNCT07619157

Ono Pharmaceutical Co., Ltd.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Type2 Diabetes Mellitus Chronic Kidney Disease

Interventions

ONO-3310DRUG

Single oral dose of ONO-3310 to HV

PlaceboDRUG

Single oral dose of Placebo to HV

ONO-3310DRUG

Multiple oral dose of ONO-3310 to HV

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, Japan

RECRUITING

Outcomes

Primary Outcomes

Adverse event

Number of participants with adverse events

Time frame: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)

Maximum plasma observed concentration (Cmax)