A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Shionogi

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: S-217622

Study type: Interventional

Funder types: Industry

Identifiers

NCT05409911

2127T1213

Details and patient eligibility

About

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.

Enrollment: 25 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 Hepatic Impairment

• A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography [CT] scan, magnetic resonance imaging [MRI], or ultrasonography).

• Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:

  1. Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
  2. Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)

• 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

• Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).

Exclusion criteria

• History or presence of/significant history of or current cardiovascular, respiratory, renal, 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.
• 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.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

S-217622: Group A

Experimental group

Description:

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

Treatment:

Drug: S-217622