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

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT07619157
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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

Key Dates

First listed
Jun 1, 2026
Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single-dose ONO-3310
  • Placebo Comparator: Single-dose placebo
  • Experimental: Multiple-dose ONO-3310
  • Placebo Comparator: Multiple-dose placebo
  • Experimental: Single- and multiple-dose ONO-3310

Primary Outcome Measure

Adverse event [ Time Frame: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD) ]

Central Contacts

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