NCT07619157RecruitingPhase 1
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
Ono Pharmaceutical Co., Ltd.1 site in 1 country120 target enrollmentStarted: June 2, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
Study Overview
Brief Summary
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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
In HV part, ONO-3310 or placebo will be administered in blinded manner. In CKD part, no masking will be conducted (open label).
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
Study Sites (1)
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