A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
NCT07217886 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-10-30
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.
Conditions
- Renal Impairment
Interventions
- DRUG
-
S-892216-PO
S-892216-PO tablet will be administered orally.
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
Shionogi
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-16
- Primary Completion
- 2026-06-05
- Completion
- 2026-06-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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