A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: warfarin+atorvastatin+IBI362
|
Drug: IBI362
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.
Drug: warfarin
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.
Drug: atorvastatin
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.
|
| Experimental: metformin+digoxin+IBI362
|
Drug: metformin
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.
Drug: digoxin
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.
Drug: IBI362
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
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Have dysphagia or any history of gastrointestinal diseases that affect drug absorption.
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Medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aerospace Center Hospital | Beijing | Beijing | China | 100049 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI362D101