A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

Conditions
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Overweight Subjects, Obese Subjects

Intervention / Treatment
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* Drug: metformin
* Drug: digoxin
* Drug: IBI362
* Drug: warfarin
* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warfarin+atorvastatin+IBI362<br> | Drug: IBI362<br>* Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.<br>Drug: warfarin<br>* For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.<br>Drug: atorvastatin<br>* For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.<br>|
| Experimental: metformin+digoxin+IBI362<br> | Drug: metformin<br>* For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.<br>Drug: digoxin<br>* For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.<br>Drug: IBI362<br>* Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed metformin plasma concentration at steady state |  | up to 116 days | 
| Area under the metformin plasma concentration-time curve |  | up to 116 days | 
| Maximum observed warfarin plasma concentration at steady state |  | up to 116 days | 
| Area under the warfarin plasma concentration-time curve |  | up to 116 days | 
| Maximum observed atorvastatin plasma concentration at steady state |  | up to 116 days | 
| Area under the atorvastatin plasma concentration-time curve |  | up to 116 days | 
| Maximum observed digoxin plasma concentration at steady state |  | up to 116 days | 
| Area under the digoxin plasma concentration-time curve |  | up to 116 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual adverse events |  | up to 116 days | 
| Terminal elimination half-life |  | up to 116 days | 
| time to maximum plasma concentration of IBI362 |  | up to 116 days | 
| Incremental area under the INR (international normalised ratio) -curve of warfarin |  | up to 116 days | 
| Total apparent clearance of IBI362 |  | up to 116 days | 
| Apparent volume of distribution of IBI362 |  | up to 116 days |