A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants

NCT05363215 | Completed Phase 1 FDA Drug

• 1 other identifier: 2128T1214
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Renal 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 S217622

  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 (4)

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.

Drug: S-217622

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.

Drug: S-217622

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.

Drug: S-217622

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.

Drug: S-217622

Interventions

S-217622 DRUG

Tablet for oral administration

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

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 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:
• Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m\^2
• Moderate renal impairment: 30 to 59 mL/min/1.73 m\^2
• Severe renal impairment: No lower limit of eGFR, \<30 mL/min
• 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
• Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by MDRD, must be normal (ie, eGFR \> 90 mL/min/1.73 m\^2).
• Matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).

You may not qualify if:

• Participants with life expectancy less than 3 months.
• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, 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.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• 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

Conditions

Renal Insufficiency

Interventions

ensitrelvir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: May 3, 2022
• First Posted: May 5, 2022
• Study Start: August 10, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

US (4)