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Completed

NCT Number: NCT05409911

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Pharma CR, LLC, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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%).

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.

Treatment and study plan

S-217622

Drug

Tablet for oral administration

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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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