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

Phase 1

Completed

• Conditions: Overweight Subjects; Obese Subjects
• Interventions: Drug: metformin; Drug: warfarin; Drug: digoxin; Drug: IBI362; Drug: atorvastatin

• Registration Number: NCT05815680
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-04
• Study Start: 2023-04-06
• Study First Posted: 2023-04-18
• Primary Completion: 2023-08-18
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
metformin+digoxin+IBI362	IBI362	-
warfarin+atorvastatin+IBI362	IBI362	-
warfarin+atorvastatin+IBI362	warfarin	-
warfarin+atorvastatin+IBI362	atorvastatin	-
metformin+digoxin+IBI362	metformin	-
metformin+digoxin+IBI362	digoxin	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
time to maximum plasma concentration of IBI362	up to 116 days
Incremental area under the INR (international normalised ratio) -curve of warfarin	up to 116 days
Actual adverse events	up to 116 days
Terminal elimination half-life	up to 116 days
Apparent volume of distribution of IBI362	up to 116 days
Total apparent clearance of IBI362	up to 116 days

Trial Locations

Locations (1)

Aerospace Center Hospital; 🇨🇳 Beijing, Beijing, China