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NCT Number: NCT07619157

A Study 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

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Key information

Conditions

Type2 Diabetes Mellitus Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Hakata Clinic

Fukuoka, Japan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-3310

Drug

Single oral dose of ONO-3310 to HV

Placebo

Drug

Single oral dose of Placebo to HV

Primary outcomes

  1. Adverse event

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

    Number of participants with adverse events

  2. Maximum plasma observed concentration (Cmax)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  3. Time to reach maximum observed concentration (Tmax)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  4. Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24h)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  5. Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  6. Area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUClast)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  7. Elimination half-life (T1/2)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  8. Apparent total clearance (CL/F)

    Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

  9. Urinary excretion rate of unchanged drug

    Time frame: Up to 6 days (HV single)

  10. Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)

    Time frame: Up to 74 days (CKD)

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777

Ono Pharmaceutical Co., Ltd.

CONTACT

[email protected]

+18665877745

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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