Actively Recruiting
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of S-892216-PO in Adults With Renal Impairment and Matched Controls
Led by Shionogi · Updated on 2025-10-30
40
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shionogi
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to measure how the drug S-892216-PO behaves in the body, and to evaluate its safety and tolerability in adults with different levels of kidney function. It includes participants with mild, moderate, or severe kidney impairment not on dialysis, those requiring hemodialysis, and those with normal kidney function. The study is a phase 1, open-label trial designed to compare these groups and understand drug behavior in each. Participants in the study will receive oral doses of S-892216-PO. The study includes several groups based on kidney function: severe impairment without dialysis, renal impairment requiring hemodialysis, normal kidney function, moderate impairment, and mild impairment. Each group receives the same study drug to assess differences in drug levels and effects. During the study, participants will undergo medical evaluations including clinical labs, vital signs, and heart monitoring to assess safety. Researchers will measure drug concentrations in the blood and dialysate over specific time points, focusing on maximum plasma concentration and area under the curve after dosing. The study also tracks any adverse events from the time of dosing through follow-up. Participation involves screening, dosing, monitoring, and safety assessments up to Day 39, with detailed pharmacokinetic sampling especially for those on dialysis.
CONDITIONS
Brief Title
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Medically stable or healthy based on medical evaluation including history, physical exam, labs, vital signs, and ECG
- For renal impairment groups: diagnosed mild, moderate, or severe kidney impairment based on eGFR and body surface area
- For hemodialysis group: receiving stable hemodialysis at least 3 times weekly for 6 months prior to screening
- For normal kidney function group: normal clinical lab tests and eGFR ≥90 mL/min
You will not qualify if you...
- Life expectancy of 3 months or less
- Cardiovascular, respiratory, liver, gastrointestinal, endocrine, blood, or neurological disorders that affect drug absorption, metabolism, or elimination, or interfere with data interpretation
- For normal kidney function group: history or presence of kidney disorders affecting drug processing
- For renal impairment groups: clinically significant lab abnormalities or values outside protocol limits during screening
- For renal impairment groups not on hemodialysis: current or expected need for hemodialysis during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Participants receive oral doses of S-892216-PO according to their renal function group to evaluate pharmacokinetics, safety, and tolerability.
Multiple visits during the treatment period including Day 1 and Day 29 assessments
Duration - Up to 10 days after treatment ends
Participants are monitored for treatment-emergent adverse events and safety up to Day 39 after dosing.
Visits up to Day 39 for safety monitoring
Trial Site Locations
Total: 4 locations
1
Orlando Clicinal Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States, 33705
Actively Recruiting
3
Genesis Clinical Research
Tampa, Florida, United States, 33603
Actively Recruiting
4
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
S
Shionogi Clinical Trials Administrator Clinical Support Help Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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