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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-217622 | Drug | Tablet for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events | Up to Day 21 |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States | ||
| Advanced Pharma CR, LLC |
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| ID | Term |
|---|---|
| C000722354 | ensitrelvir |
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| 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 |
| Miami |
| Florida |
| 33147 |
| United States |
| Orlando Clinical Research Center, Inc. | Orlando | Florida | 32809 | United States |
| Nucleus Network | Saint Paul | Minnesota | 55114 | United States |