Clinical trial NCT05793450: Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
Official title: Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility criteria: Inclusion Criteria:

* All Participants:

  o The weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (BMI) is within the range of 20\~30 kilograms per meter squared (kg/m²), inclusive, at screening
* Healthy Participants:

  -- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening
* Participants with Renal Impairment:

  * Males or females with stable mild to severe renal impairment, assessed by eGFR

Exclusion Criteria:

* All Participants:

  * Pregnant or lactating women, or men or women who are of childbearing potential and are not willing to use contraception within 6 months from the screening period to the administration of the study drug
  * Have known allergies to IBI362 or related compounds
  * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
  * Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5× the upper limit of normal (ULN) or total bilirubin (TBL) \>1× ULN
  * Severe gastrointestinal diseases (such as active ulcer, pyloric obstruction, inflammatory bowel disease, etc.) occurred within 6 months before screening, or received gastrointestinal surgery or long-term use of drugs that directly affect gastrointestinal motility due to chronic gastrointestinal diseases
  * Have a history of acute and chronic pancreatitis, or serum amylase and/or lipase ≥ 1.5× ULN at screening, or fasting Triglyceride ≥ 5.64 mmol/L (500 mg/dl)
* Participants with Renal Impairment:

  * obstructive urinary tract diseases (such as urinary stones, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or renal dysfunction caused by special types of renal parenchymal damage (such as polycystic kidney, medullary sponge kidney, Renal tumors, etc.) and/or patients with renal impairment who have diseases that are not related to renal disease but can cause renal impairment (eg, renal artery stenosis, acute drug injury, severe infection, hypovolemia, heart failure, etc.).
  * Have a history of kidney transplant
  * The treatment medication and/or the treatment medication of other comorbid diseases have been taken stably for less than 1 month at screening, or there are new medications within 1 month before screening (except temporary or intermittent use of drugs, such as Erythropoietin once a month, or diuretics as needed, etc.), or received any drug known to alter renal tubular creatinine secretion within 14 days or 5 half-lives before screening, such as cimetidine D, trimethoprim or cibenzoline, etc.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
timeFrame: Predose through 1344 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362
timeFrame: Predose through 1344 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
Study officials:
References: