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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363215
• Other study ID #: 2128T1214
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• S-217622
Tablet for oral administration

Locations

Country	Name	City	State
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Orlando Clinical Research Center, Inc.	Orlando	Florida
United States	Nucleus Network	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Time to Maximum Plasma Concentration (Tmax) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Area Under the Plasma Concentration-Time Curve (AUC) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Terminal Elimination Half-Life (t1/2,z) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Terminal Elimination Rate Constant (?z) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Mean Residence Time (MRT) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Apparent Total Clearance (CL/F) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Apparent Volume of Distribution (Vz/F) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Renal Clearance (CLR) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Fraction of Dose Excreted in Urine (Feu) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Fraction Unbound in Plasma (FU) of S217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Secondary	Number of Participants with Treatment-Emergent Adverse Events		Up to Day 21