Clinical trial NCT05815680: A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Official title: A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight Subjects
Obese Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in China. The aim of the trial is to investigate the influence of IBI362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin, metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects.


Eligibility criteria: Inclusion Criteria:

* Male, age between 18 and 45 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 24 and 30 kg/m\^2 (both inclusive) and weight≥50kg
* The subject has no birth plan and voluntarily takes effective contraceptive measures within 6 months after signing the informed consent form to the last medication

Exclusion Criteria:

* Cardiovascular, respiratory, hepatic, digestive (including digestive diseases that significantly affect gastric emptying or gastric motility, such as severe gastric spasticity or pyloric stenosis), endocrine (including but not limited to history of thyroid cancer or precancerous lesions), hematological and neurological disorders, or muscle degenerative disorders
* Drug or alcohol abuse
* Have dysphagia or any history of gastrointestinal diseases that affect drug absorption.
* Medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have a history of acute and chronic pancreatitis or serum amylase and/or lipase ≥ upper limit of normal value (Upper Limit of Normal value, ULN) at the time of screening.
* Those with a history of hypoglycemia.
* Previous or current mental illness.

Primary outcomes:
measure: Maximum observed metformin plasma concentration at steady state
timeFrame: up to 116 days
measure: Area under the metformin plasma concentration-time curve
timeFrame: up to 116 days
measure: Maximum observed warfarin plasma concentration at steady state
timeFrame: up to 116 days
measure: Area under the warfarin plasma concentration-time curve
timeFrame: up to 116 days
measure: Maximum observed atorvastatin plasma concentration at steady state
timeFrame: up to 116 days
measure: Area under the atorvastatin plasma concentration-time curve
timeFrame: up to 116 days
measure: Maximum observed digoxin plasma concentration at steady state
timeFrame: up to 116 days
measure: Area under the digoxin plasma concentration-time curve
timeFrame: up to 116 days
Secondary outcomes:
measure: Actual adverse events
timeFrame: up to 116 days
measure: Terminal elimination half-life
timeFrame: up to 116 days
measure: time to maximum plasma concentration of IBI362
timeFrame: up to 116 days
measure: Incremental area under the INR (international normalised ratio) -curve of warfarin
timeFrame: up to 116 days
measure: Total apparent clearance of IBI362
timeFrame: up to 116 days
measure: Apparent volume of distribution of IBI362
timeFrame: up to 116 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
Study officials:
References: