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

NCT05409911 | Completed Phase 1 FDA Drug

• 1 other identifier: 2127T1213
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (11)

• Maximum Observed Plasma Concentration (Cmax) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Time to Maximum Plasma Concentration (Tmax) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Area Under the Plasma Concentration-Time Curve (AUC) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Terminal Elimination Half-Life (t1/2,z) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Terminal Elimination Rate Constant (λz) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Mean Residence Time (MRT) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Apparent Total Clearance (CL/F) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Apparent Volume of Distribution (Vz/F) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Renal Clearance (CLR) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Fraction of Dose Excreted in Urine (Feu) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

• Fraction Unbound in Plasma (FU) of S-217622

  0 (predose) up to 336 hours postdose on Day 1 to Day 15

Secondary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events

  Up to Day 21

Study Arms (3)

S-217622: Group A

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

Drug: S-217622

S-217622: Group B

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

Drug: S-217622

S-217622: Group C

EXPERIMENTAL

Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state.

Drug: S-217622

Interventions

S-217622 DRUG

Tablet for oral administration

S-217622: Group A; S-217622: Group B; S-217622: Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (4)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Orlando Clinical Research Center, Inc.

Orlando, Florida, 32809, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

ensitrelvir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: September 13, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

US (4)