Back to resultsA Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Primary Purpose
Overweight Subjects, Obese Subjects
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
metformin
digoxin
IBI362
warfarin
atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Overweight Subjects
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.
Sites / Locations
- Aerospace Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
warfarin+atorvastatin+IBI362
metformin+digoxin+IBI362
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed metformin plasma concentration at steady state
Area under the metformin plasma concentration-time curve
Maximum observed warfarin plasma concentration at steady state
Area under the warfarin plasma concentration-time curve
Maximum observed atorvastatin plasma concentration at steady state
Area under the atorvastatin plasma concentration-time curve
Maximum observed digoxin plasma concentration at steady state
Area under the digoxin plasma concentration-time curve
Secondary Outcome Measures
Actual adverse events
Terminal elimination half-life
time to maximum plasma concentration of IBI362
Incremental area under the INR (international normalised ratio) -curve of warfarin
Total apparent clearance of IBI362
Apparent volume of distribution of IBI362
Full Information
NCT ID
NCT05815680
First Posted
March 20, 2023
Last Updated
May 18, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05815680
Brief Title
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Official Title
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
October 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight Subjects, Obese Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
warfarin+atorvastatin+IBI362
Arm Type
Experimental
Arm Title
metformin+digoxin+IBI362
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
digoxin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum observed metformin plasma concentration at steady state
Time Frame
up to 116 days
Title
Area under the metformin plasma concentration-time curve
Time Frame
up to 116 days
Title
Maximum observed warfarin plasma concentration at steady state
Time Frame
up to 116 days
Title
Area under the warfarin plasma concentration-time curve
Time Frame
up to 116 days
Title
Maximum observed atorvastatin plasma concentration at steady state
Time Frame
up to 116 days
Title
Area under the atorvastatin plasma concentration-time curve
Time Frame
up to 116 days
Title
Maximum observed digoxin plasma concentration at steady state
Time Frame
up to 116 days
Title
Area under the digoxin plasma concentration-time curve
Time Frame
up to 116 days
Secondary Outcome Measure Information:
Title
Actual adverse events
Time Frame
up to 116 days
Title
Terminal elimination half-life
Time Frame
up to 116 days
Title
time to maximum plasma concentration of IBI362
Time Frame
up to 116 days
Title
Incremental area under the INR (international normalised ratio) -curve of warfarin
Time Frame
up to 116 days
Title
Total apparent clearance of IBI362
Time Frame
up to 116 days
Title
Apparent volume of distribution of IBI362
Time Frame
up to 116 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Aerospace Center Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100049
Country
China
12. IPD Sharing Statement
Learn more about this trial
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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