A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls

Part of paid clinical trials in Orlando, Florida.

Sponsor
Shionogi
Study ID
NCT07217886
Phase
PHASE1
Status
Recruiting
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Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • S-892216-PO — DRUG
    S-892216-PO tablet will be administered orally.

Study Details

The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.

Key Dates

Start date
Oct 16, 2025
Status verified
Oct 2025
Primary completion
Jun 5, 2026
Completion
Jun 5, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (Severe Renal Impairment)
    Participants with severe renal impairment not on HD will receive S-892216-PO.
  • Experimental: Group B (Renal Impairment)
    Participants with renal impairment requiring HD will receive S-892216-PO.
  • Experimental: Group C (Normal Renal Function)
    Participants with normal renal function will receive S-892216-PO.
  • Experimental: Group D (Moderate Renal Impairment)
    Participants with moderate impairment will receive S-892216-PO.
  • Experimental: Group D (Mild Renal Impairment)
    Participants with mild impairment will receive S-892216-PO.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of S-892216 [ Time Frame: Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    1-800-849-9707
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Orlando Clicinal Research CenterOrlandoFlorida32809-
Global Clinical Professionals (GCP) LLCSt. PetersburgFlorida33705-
Genesis Clinical ResearchTampaFlorida33603-
Alliance for Multispecialty Research (AMR)-KnoxvilleKnoxvilleTennessee37920-

Find similar trials in Orlando, FL

By research site
Orlando Clicinal Research Center· Orlando, FLGlobal Clinical Professionals (GCP) LLC· St. Petersburg, FLGenesis Clinical Research· Tampa, FLAlliance for Multispecialty Research (AMR)-Knoxville· Knoxville, TN

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