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

Hepatic Impairment Clinical Trial

Official title:

A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409911
• Other study ID #: 2127T1213
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with normal hepatic function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• S-217622
Tablet for oral administration

Locations

Country	Name	City	State
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Orlando Clinical Research Center, Inc.	Orlando	Florida
United States	Nucleus Network	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Time to Maximum Plasma Concentration (Tmax) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Area Under the Plasma Concentration-Time Curve (AUC) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Terminal Elimination Half-Life (t1/2,z) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Terminal Elimination Rate Constant (?z) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Mean Residence Time (MRT) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Apparent Total Clearance (CL/F) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Apparent Volume of Distribution (Vz/F) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Renal Clearance (CLR) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Fraction of Dose Excreted in Urine (Feu) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Primary	Fraction Unbound in Plasma (FU) of S-217622		0 (predose) up to 336 hours postdose on Day 1 to Day 15
Secondary	Number of Participants with Treatment-Emergent Adverse Events		Up to Day 21