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

NCT ID: NCT05363215

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-04-12

Brief 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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-217622: Group A

Participants with mild renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

Group Type: EXPERIMENTAL

S-217622

Intervention Type: DRUG

Tablet for oral administration

S-217622: Group B

Participants with moderate renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

Group Type: EXPERIMENTAL

S-217622

Intervention Type: DRUG

Tablet for oral administration

S-217622: Group C

Participants with severe renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

Group Type: EXPERIMENTAL

S-217622

Intervention Type: DRUG

Tablet for oral administration

S-217622: Group D

Participants with normal renal function will receive a single dose of S-217622 on Day 1, in a fasted state.

Group Type: EXPERIMENTAL

S-217622

Intervention Type: DRUG

Tablet for oral administration

Interventions

S-217622

Tablet for oral administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Advanced Pharma CR, LLC

Miami, Florida, United States

Orlando Clinical Research Center, Inc.

Orlando, Florida, United States

Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

2128T1214

Identifier Type: -

Identifier Source: org_study_id