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

Shionogi

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: S-217622

Study type: Interventional

Funder types: Industry

Identifiers

NCT05363215

2128T1214

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

S-217622: Group A

Experimental group

Description:

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

Treatment:

Drug: S-217622

S-217622: Group B

Experimental group

Description:

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

Treatment:

Drug: S-217622

S-217622: Group C

Experimental group

Description:

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

Treatment:

Drug: S-217622

S-217622: Group D

Experimental group

Description:

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

Treatment:

Drug: S-217622