A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls

NCT07217886 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2420T1614
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.

Conditions

Renal Impairment

Keywords

S-892216; Hemodialysis; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax) of S-892216

  Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only

• Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216

  Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only

• Group B Only: Cumulative Amount of the Drug Recovered in Dialysate (AHD) of S-892216

  Day 1 (up to 6 hours postdose)

• Group B Only: Area Under the Dialysate Concentration in the Arterial Sides of Port-time Curve During Hemodialysis (AUChd) of S-892216

  Day 1 (up to 6 hours postdose)

Secondary Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Day 1 through Day 39

Study Arms (5)

Group A (Severe Renal Impairment)

EXPERIMENTAL

Participants with severe renal impairment not on HD will receive S-892216-PO.

Drug: S-892216-PO

Group B (Renal Impairment)

EXPERIMENTAL

Participants with renal impairment requiring HD will receive S-892216-PO.

Drug: S-892216-PO

Group C (Normal Renal Function)

EXPERIMENTAL

Participants with normal renal function will receive S-892216-PO.

Drug: S-892216-PO

Group D (Moderate Renal Impairment)

EXPERIMENTAL

Participants with moderate impairment will receive S-892216-PO.

Drug: S-892216-PO

Group D (Mild Renal Impairment)

EXPERIMENTAL

Participants with mild impairment will receive S-892216-PO.

Drug: S-892216-PO

Interventions

S-892216-PO DRUG

S-892216-PO tablet will be administered orally.

Group A (Severe Renal Impairment); Group B (Renal Impairment); Group C (Normal Renal Function); Group D (Mild Renal Impairment); Group D (Moderate Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (4)

Orlando Clicinal Research Center

Orlando, Florida, 32809, United States

RECRUITING

Global Clinical Professionals (GCP) LLC

St. Petersburg, Florida, 33705, United States

RECRUITING

Genesis Clinical Research

Tampa, Florida, 33603, United States

RECRUITING

Alliance for Multispecialty Research (AMR)-Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

1-800-849-9707; Shionogiclintrials-admin@shionogi.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)