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S-217622 for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Shionogi
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 weeks
Treatment ~ Varies
Follow Up ~0 (predose) up to 336 hours postdose on day 1 to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (predose) up to 336 hours postdose on day 1 to day 15 for reporting.

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 more
Secondary 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
116 Previous Clinical Trials
41,454 Total Patients Enrolled
~11 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
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