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CompletedNCT05409911Updated May 26, 2023

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

A Phase 1 interventional study of S-217622 in Hepatic Impairment, sponsored by Shionogi. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-26.

Sponsored by Shionogi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2023, 3 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic Impairment

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03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Shionogi is the lead sponsor of 104 studies on the registry; 10 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    S-217622: Group A

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

    Drug: S-217622

  • Experimental
    S-217622: Group B

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

    Drug: S-217622

  • Experimental
    S-217622: Group C

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

    Drug: S-217622

Interventions

  • DrugS-217622

    Tablet for oral administration

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of S-217622

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

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

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

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

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

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

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

  5. Terminal Elimination Rate Constant (λz) of S-217622

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

  6. Mean Residence Time (MRT) of S-217622

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

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

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

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

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

  9. Renal Clearance (CLR) of S-217622

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

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

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

  11. Fraction Unbound in Plasma (FU) of S-217622

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

Secondary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events

    Time frame: Up to Day 21

07

Study locations

4 sites
  • Clinical Pharmacology of Miami, LLC
    Miami, Florida 33014, United States
  • Advanced Pharma CR, LLC
    Miami, Florida 33147, United States
  • Orlando Clinical Research Center, Inc.
    Orlando, Florida 32809, United States
  • Nucleus Network
    Saint Paul, Minnesota 55114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05409911
Lead sponsor
Shionogi
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
Sep 13, 2022
Primary completion
Apr 25, 2023
Completion
Apr 25, 2023
Last update
May 26, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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