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

Overweight Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815680
• Other study ID #: CIBI362D101
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 30, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

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.

Related Conditions & MeSH terms

• Overweight
• Overweight Subjects

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed metformin plasma concentration at steady state		up to 116 days
Primary	Area under the metformin plasma concentration-time curve		up to 116 days
Primary	Maximum observed warfarin plasma concentration at steady state		up to 116 days
Primary	Area under the warfarin plasma concentration-time curve		up to 116 days
Primary	Maximum observed atorvastatin plasma concentration at steady state		up to 116 days
Primary	Area under the atorvastatin plasma concentration-time curve		up to 116 days
Primary	Maximum observed digoxin plasma concentration at steady state		up to 116 days
Primary	Area under the digoxin plasma concentration-time curve		up to 116 days
Secondary	Actual adverse events		up to 116 days
Secondary	Terminal elimination half-life		up to 116 days
Secondary	time to maximum plasma concentration of IBI362		up to 116 days
Secondary	Incremental area under the INR (international normalised ratio) -curve of warfarin		up to 116 days
Secondary	Total apparent clearance of IBI362		up to 116 days
Secondary	Apparent volume of distribution of IBI362		up to 116 days