Clinical trial NCT05363215: A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
Official title: A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild, Moderate, and Severe Renal Impairment and Healthy Control Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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:

  1. Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m\^2
  2. Moderate renal impairment: 30 to 59 mL/min/1.73 m\^2
  3. 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%).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Time to Maximum Plasma Concentration (Tmax) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Terminal Elimination Half-Life (t1/2,z) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Terminal Elimination Rate Constant (λz) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Mean Residence Time (MRT) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Apparent Total Clearance (CL/F) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Apparent Volume of Distribution (Vz/F) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Renal Clearance (CLR) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Fraction of Dose Excreted in Urine (Feu) of S-217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
measure: Fraction Unbound in Plasma (FU) of S217622
timeFrame: 0 (predose) up to 336 hours postdose on Day 1 to Day 15
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events
timeFrame: Up to Day 21
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center, Inc.
state: Florida
city: Saint Paul
country: United States
facility: Nucleus Network
state: Minnesota
Study officials:
References: