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New treatment option for Type2 Diabetes Mellitus
Official title A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07619157
What this study is testing
What is ONO-3310?
ONO-3310 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type2 diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adult part
- Japanese healthy adult male people
- 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
You likely can't join if
- Healthy adult part
- people who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric...
- 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...
- Patients with type 1 diabetes mellitus
See the full eligibility criteria
- Healthy adult part
- Japanese healthy adult male people
- 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
- Healthy adult part
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.