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
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram during the screening period and on Day -1. * Participants With Severe, Moderate, and Mild Renal Impairment not on HD (Group A, D and E): Participants that are not undergoing HD and have mild, moderate, or severe renal impairment based upon the 2021 Chronic Kidney Disease Epidem…
Interventions
- DrugS-892216-PO
S-892216-PO tablet will be administered orally.
Locations (4)
- Orlando Clicinal Research CenterOrlando, Florida
- Global Clinical Professionals (GCP) LLCSt. Petersburg, Florida
- Genesis Clinical ResearchTampa, Florida
- Alliance for Multispecialty Research (AMR)-KnoxvilleKnoxville, Tennessee