A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorOno Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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/m²
Chronic kidney disease patients with type 2 diabetes mellitus
Disqualifiers
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
Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease
Trial design
Treatments tested in this trial
- ONO-3310
- Placebo
- ONO-3310
- Placebo
- ONO-3310
Treatment groups
120 Participants
are divided into 5 treatment groupsLocations
1Souseikai Hakata Clinic FukuokaFukuoka, Japan
Sponsors and collaborators
Ono Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov