Health TrialsbyHealthPanel

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

ConditionsType2 Diabetes MellitusChronic Kidney Disease
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • ONO-3310

    Drug

    Single oral dose of ONO-3310 to HV

  • Placebo

    Drug

    Single oral dose of Placebo to HV

  • ONO-3310

    Drug

    Multiple oral dose of ONO-3310 to HV

  • Placebo

    Drug

    Multiple oral dose of Placebo to HV

  • ONO-3310

    Drug

    Single or multiple oral dose of ONO-3310 to CKD patients

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: Single-dose ONO-3310Experimental treatment 1 intervention
Group B: Single-dose placeboPlacebo comparator 1 intervention
Group C: Multiple-dose ONO-3310Experimental treatment 1 intervention
Group D: Multiple-dose placeboPlacebo comparator 1 intervention
Group E: Single- and multiple-dose ONO-3310Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse event

Number of participants with adverse events

Time frame
Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)
2

Maximum plasma observed concentration (Cmax)

Time frame
Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
3

Time to reach maximum observed concentration (Tmax)

Time frame
Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
4

Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24h)

Time frame
Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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