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The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-217622: Group A | Experimental | Participants with mild renal 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 renal 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 severe renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state. |
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| S-217622: Group D | Experimental | Participants with normal renal 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 |
|
| 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 Renal Impairment
Participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their Modification of Diet in Renal Disease (MDRD) creatinine clearance estimate (estimated glomerular filtration rate [eGFR]) calculated at the Screening visit:
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:
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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 |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 S217622 | 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |