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

RecruitingPhase 1Ages 18 Years - 64 YearsAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • ONO-3310
  • Placebo
  • ONO-3310
  • Placebo
  • ONO-3310
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Where

1 site
Souseikai Hakata Clinic
Fukuoka, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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