Status:
COMPLETED
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Lead Sponsor:
Shionogi
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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%).
Exclusion
- 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.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05409911
Start Date
September 13 2022
End Date
April 25 2023
Last Update
May 26 2023
Active Locations (4)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
2
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
3
Orlando Clinical Research Center, Inc.
Orlando, Florida, United States, 32809
4
Nucleus Network
Saint Paul, Minnesota, United States, 55114