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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT05409911

Run by

Shionogi

People needed

25

Starts

2022-09-13

Expected to finish

2023-04-25

Last updated by the study team

2023-05-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
• 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%).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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