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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (predose) up to 336 hours postdose on day 1 to day 15
Awards & highlights
Study Summary
This trial is testing a new drug to see how well it works and how safe it is for people with different levels of kidney function.
Eligible Conditions
- Kidney Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (predose) up to 336 hours postdose on day 1 to day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (predose) up to 336 hours postdose on day 1 to day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Total Clearance (CL/F) of S-217622
Apparent Volume of Distribution (Vz/F) of S-217622
Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
+8 moreSecondary outcome measures
Number of Participants with Treatment-Emergent Adverse Events
Trial Design
4Treatment groups
Experimental Treatment
Group I: S-217622: Group DExperimental Treatment1 Intervention
Participants with normal renal function will receive a single dose of S-217622 on Day 1, in a fasted state.
Group II: S-217622: Group CExperimental Treatment1 Intervention
Participants with severe renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Group III: S-217622: Group BExperimental Treatment1 Intervention
Participants with moderate renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Group IV: S-217622: Group AExperimental Treatment1 Intervention
Participants with mild renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S-217622
2022
Completed Phase 1
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ShionogiLead Sponsor
115 Previous Clinical Trials
41,229 Total Patients Enrolled
Frequently Asked Questions
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