S-217622 for deteriorating renal function

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Orlando Clinical Research Center, Inc, Orlando, FL
deteriorating renal function+1 More
S-217622 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.

Eligible Conditions

  • deteriorating renal function

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for deteriorating renal function

Study Objectives

11 Primary · 1 Secondary · Reporting Duration: 0 (predose) up to 336 hours postdose on Day 1 to Day 15

Day 15
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
Fraction Unbound in Plasma (FU) of S217622
Fraction of Dose Excreted in Urine (Feu) of S-217622
Maximum Observed Plasma Concentration (Cmax) of S-217622
Mean Residence Time (MRT) of S-217622
Renal Clearance (CLR) of S-217622
Terminal Elimination Half-Life (t1/2,z) of S-217622
Terminal Elimination Rate Constant (λz) of S-217622
Time to Maximum Plasma Concentration (Tmax) of S-217622
Up to Day 21
Number of Participants with Treatment-Emergent Adverse Events

Trial Safety

Safety Progress

1 of 3

Other trials for deteriorating renal function

Trial Design

4 Treatment Groups

S-217622: Group D
1 of 4
S-217622: Group C
1 of 4
S-217622: Group B
1 of 4
S-217622: Group A
1 of 4
Experimental Treatment

64 Total Participants · 4 Treatment Groups

Primary Treatment: S-217622 · No Placebo Group · Phase 1

S-217622: Group D
Drug
Experimental Group · 1 Intervention: S-217622 · Intervention Types: Drug
S-217622: Group C
Drug
Experimental Group · 1 Intervention: S-217622 · Intervention Types: Drug
S-217622: Group B
Drug
Experimental Group · 1 Intervention: S-217622 · Intervention Types: Drug
S-217622: Group A
Drug
Experimental Group · 1 Intervention: S-217622 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (predose) up to 336 hours postdose on day 1 to day 15
Closest Location: Orlando Clinical Research Center, Inc · Orlando, FL
Photo of Orlando  1Photo of Orlando  2Photo of Orlando  3
2022First Recorded Clinical Trial
1 TrialsResearching deteriorating renal function
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have mild renal impairment.
You have moderate renal impairment.
You have a moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.