Clinical trial

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

Name

CIBI362D101

Description

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.

Trial arms

Trial start

2023-04-06

Estimated PCD

2023-08-18

Trial end

2023-10-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

metformin+digoxin+IBI362

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.

Arms:

metformin+digoxin+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.

Arms:

metformin+digoxin+IBI362, warfarin+atorvastatin+IBI362

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.

Arms:

warfarin+atorvastatin+IBI362

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.

Arms:

warfarin+atorvastatin+IBI362

Size

Primary endpoint

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2023-11-14

1 organization

5 products

2 indications

Product

metformin

Indication

Overweight Subjects

Indication

Obese Subjects

Organization