ONO-3310: Single or multiple oral dose of ONO-3310 to CKD patients
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Adverse event — Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD) Number of participants with adverse events
Maximum plasma observed concentration (Cmax) — Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Time to reach maximum observed concentration (Tmax) — 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) — 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) — 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) — Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Elimination half-life (T1/2) — Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Apparent total clearance (CL/F) — Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Urinary excretion rate of unchanged drug — Up to 6 days (HV single)
Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio) — Up to 74 days (CKD)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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