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Recruiting NCT07619157

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

Phase I Interventional Type2 Diabetes Mellitus Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ONO-3310, Placebo, ONO-3310, Placebo.
Who it may be relevant to
Registry conditions: Type2 Diabetes Mellitus, Chronic Kidney Disease. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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

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.

Interventions

  • Drug ONO-3310
    Single oral dose of ONO-3310 to HV
  • Drug Placebo
    Single oral dose of Placebo to HV
  • Drug ONO-3310
    Multiple oral dose of ONO-3310 to HV
  • Drug Placebo
    Multiple oral dose of Placebo to HV
  • Drug ONO-3310
    Single or multiple oral dose of ONO-3310 to CKD patients

Primary outcome measures

  • Adverse event [Time frame: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)]
  • Maximum plasma observed concentration (Cmax) [Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)]
  • Time to reach maximum observed concentration (Tmax) [Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)]
  • 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)]
  • 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)]
  • 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)]
  • Elimination half-life (T1/2) [Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)]
  • Apparent total clearance (CL/F) [Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)]
  • Urinary excretion rate of unchanged drug [Time frame: Up to 6 days (HV single)]
  • Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio) [Time frame: Up to 74 days (CKD)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Souseikai Hakata Clinic — Fukuoka

Identifiers

NCT: NCT07619157 · ONO-3310-01 · jRCT2071260026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗