A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
NCT ID: NCT05815680
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2023-04-06
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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warfarin+atorvastatin+IBI362
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.
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.
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.
metformin+digoxin+IBI362
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Aerospace Center Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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CIBI362D101
Identifier Type: -
Identifier Source: org_study_id
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