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.
Status
Completed
Phase
Phase 1
Enrollment
48
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
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
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
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
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
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.
Timeline
First posted
Apr 18, 2023
Study start
Apr 6, 2023
Primary completion
Aug 18, 2023
Study completion
Oct 30, 2023
Results posted
Not reported
Registry updated
Nov 14, 2023
Outcomes
Maximum observed metformin plasma concentration at steady state
Time frame · up to 116 days
Area under the metformin plasma concentration-time curve
Time frame · up to 116 days
Maximum observed warfarin plasma concentration at steady state
Time frame · up to 116 days
Area under the warfarin plasma concentration-time curve
Time frame · up to 116 days
Maximum observed atorvastatin plasma concentration at steady state
Time frame · up to 116 days
Area under the atorvastatin plasma concentration-time curve
Time frame · up to 116 days
Maximum observed digoxin plasma concentration at steady state
Time frame · up to 116 days
Area under the digoxin plasma concentration-time curve
Time frame · up to 116 days
Actual adverse events
Time frame · up to 116 days
Terminal elimination half-life
Time frame · up to 116 days
time to maximum plasma concentration of IBI362
Time frame · up to 116 days
Incremental area under the INR (international normalised ratio) -curve of warfarin
Time frame · up to 116 days
Total apparent clearance of IBI362
Time frame · up to 116 days
Apparent volume of distribution of IBI362
Time frame · up to 116 days
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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