A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants

A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild, Moderate, and Severe Renal Impairment and Healthy Control Participants

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: S-217622

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC
    • Miami, Florida, United States, 33147
      • Advanced Pharma Cr, Llc
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center, Inc.
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range of ≥ 18.5 to < 38.0 kilogram-meter squared (kg/m^2) at the Screening visit

Participants With Renal Impairment

• Participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their Modification of Diet in Renal Disease (MDRD) creatinine clearance estimate (estimated glomerular filtration rate [eGFR]) calculated at the Screening visit:

  1. Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m^2
  2. Moderate renal impairment: 30 to 59 mL/min/1.73 m^2
  3. Severe renal impairment: No lower limit of eGFR, <30 mL/min
• A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.

Healthy Participants

• 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 MDRD, must be normal (ie, eGFR > 90 mL/min/1.73 m^2).
• Matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).

Exclusion Criteria:

• Participants with life expectancy less than 3 months.
• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (GI), 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.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• Breast cancer within the past 10 years.
• Participant with poor venous access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-217622: Group A; Participants with mild renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.	Drug: S-217622; Tablet for oral administration
Experimental: S-217622: Group B; Participants with moderate renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.	Drug: S-217622; Tablet for oral administration
Experimental: S-217622: Group C; Participants with severe renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.	Drug: S-217622; Tablet for oral administration
Experimental: S-217622: Group D; Participants with normal renal function will receive a single dose of S-217622 on Day 1, in a fasted state.	Drug: S-217622; Tablet for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Time to Maximum Plasma Concentration (Tmax) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Area Under the Plasma Concentration-Time Curve (AUC) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Terminal Elimination Half-Life (t1/2,z) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Terminal Elimination Rate Constant (λz) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Mean Residence Time (MRT) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Apparent Total Clearance (CL/F) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Apparent Volume of Distribution (Vz/F) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Renal Clearance (CLR) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Fraction of Dose Excreted in Urine (Feu) of S-217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15
Fraction Unbound in Plasma (FU) of S217622	0 (predose) up to 336 hours postdose on Day 1 to Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-Emergent Adverse Events	Up to Day 21

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 2128T1214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No