S-892216-PO for people with kidney impairment and matched controls

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

This study will test how S-892216-PO is processed by the body and how safe and tolerable it is in people with mild, moderate, or severe kidney impairment (including those on hemodialysis) compared with people with normal kidney function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shionogi Inc. (Industry-sponsored)
• Locations: 4 sites (Orlando, Florida and 3 other locations)
• Trial ID: NCT07217886 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study measures the pharmacokinetics, safety, and tolerability of oral S-892216‑PO in adults with varying degrees of renal impairment and in matched participants with normal renal function. Participants are grouped by kidney function using the 2021 CKD-EPI eGFR formula and body surface area, including groups not on dialysis (mild, moderate, severe) and a group on stable hemodialysis. Medically stable or healthy adults will undergo screening assessments and receive S-892216‑PO with serial blood sampling and safety monitoring to characterize drug levels and adverse events. The study is sponsored by Shionogi with collaboration from BARDA and is being conducted at multiple clinical research centers in Florida.

Who should consider this trial

Good fit: Ideal candidates are medically stable adults with mild, moderate, or severe kidney impairment not on dialysis, adults on stable hemodialysis (at least three times per week for at least six months), or healthy adults with normal kidney function willing to attend study visits.

Not a fit: Patients who are medically unstable, have recent acute kidney injury, cannot travel to the Florida study sites, or meet exclusion criteria such as pregnancy or disqualifying comorbidities are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the results could inform safer dosing and monitoring recommendations for S-892216‑PO in patients with different levels of kidney function, including those on hemodialysis.

How similar studies have performed: Pharmacokinetic and hemodialysis interaction studies have successfully guided dosing for many drugs, but S-892216‑PO itself appears investigational and this is the first reported renal impairment study for this compound.

Eligibility criteria

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 Epidemiology Collaboration (CKD-EPI) creatinine formula (estimated glomerular filtration rate \[eGFR\]) and the participant's body surface area (BSA) calculated at the screening visit.
* Participants With Renal Impairment Requiring HD (Group B): Receiving stable HD at least 3 times a week for at least 6 months prior to screening
* Participants With Normal Renal Function: Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by the 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 milliliters/minute).

Key Exclusion Criteria:

* Participants with life expectancy less than or equal to 3 months.
* History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data based on the judgment of the investigator.
* Participants With Normal Renal Function: History or presence of renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
* Participants With Any Renal Impairment (Groups A, B, D, and E): Participant with clinically significant laboratory values in the opinion of the investigator or outside protocol-specified ranges or limits during the screening period or on Day -1.
* Participants With Severe, Moderate, Mild Renal Impairment not on HD (Groups A, D, and E): Current or anticipated need for HD during the study.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Orlando, Florida and 3 other locations

• Orlando Clicinal Research Center — Orlando, Florida, United States (Recruiting)
• Global Clinical Professionals (GCP) LLC — St. Petersburg, Florida, United States (Recruiting)
• Genesis Clinical Research — Tampa, Florida, United States (Recruiting)
• Alliance for Multispecialty Research (AMR)-Knoxville — Knoxville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line

Conditions Renal Impairment; S-892216; Hemodialysis; Pharmacokinetics