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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05409911
Other study ID # 2127T1213
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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