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Trials / Recruiting

RecruitingNCT07217886

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Shionogi · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGS-892216-POS-892216-PO tablet will be administered orally.

Timeline

Start date
2025-10-16
Primary completion
2026-06-05
Completion
2026-06-05
First posted
2025-10-20
Last updated
2025-10-30

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07217886. Inclusion in this directory is not an endorsement.

A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls (NCT07217886) · Clinical Trials Directory