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A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Sponsor: Shionogi
Summary
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.
Official title: A Phase 1, Multicenter, Nonrandomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of S-892216-PO in Participants With Varying Degrees of Renal Impairment and Matched Control Participants With Normal Renal Function
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-10-16
Completion Date
2026-06-05
Last Updated
2025-10-30
Healthy Volunteers
Yes
Conditions
Interventions
S-892216-PO
S-892216-PO tablet will be administered orally.
Locations (4)
Orlando Clicinal Research Center
Orlando, Florida, United States
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States