Clinical trial NCT05409911: A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with normal hepatic function.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Time to Maximum Plasma Concentration (Tmax) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Terminal Elimination Half-Life (t1/2,z) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Terminal Elimination Rate Constant (λz) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Mean Residence Time (MRT) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Apparent Total Clearance (CL/F) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Apparent Volume of Distribution (Vz/F) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Renal Clearance (CLR) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Fraction of Dose Excreted in Urine (Feu) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Fraction Unbound in Plasma (FU) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events
timeFrame: Up to Day 21
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center, Inc.
state: Florida
city: Saint Paul
country: United States
facility: Nucleus Network
state: Minnesota
Study officials:
References: