Chronic Kidney Disease, Type2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGONO-3310
Single oral dose of ONO-3310 to HV
DRUGPlacebo
Single oral dose of Placebo to HV
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
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).
Intervention model description
In healthy volunteer part, ONO-3310 or placebo will be administered in parallel. In CKD part, single- or multiple-dose of ONO-3310 will be administered same patient sequentialy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Japan
Contacts
CONTACTOno Pharmaceutical Co., Ltd.
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed