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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

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Innovent Biologics

Status and phase

Completed
Phase 1

Conditions

Overweight Subjects
Obese Subjects

Treatments

Drug: IBI362
Drug: atorvastatin
Drug: warfarin
Drug: digoxin
Drug: metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05815680
CIBI362D101

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

48 participants in 2 patient groups

warfarin+atorvastatin+IBI362
Experimental group
Treatment:
Drug: IBI362
Drug: atorvastatin
Drug: warfarin
metformin+digoxin+IBI362
Experimental group
Treatment:
Drug: IBI362
Drug: digoxin
Drug: metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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