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

• Status: Not yet recruiting
• Trial end date: 2023-10-13
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Atorvastatin; Digoxin; Metformin; Warfarin

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.