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

NCT05815680 | Completed Phase 1

• 1 other identifier: CIBI362D101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight Subjects; Obese Subjects

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Actual adverse events

  up to 116 days

• Terminal elimination half-life

  up to 116 days

• 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

• Total apparent clearance of IBI362

  up to 116 days

Study Arms (2)

warfarin+atorvastatin+IBI362

EXPERIMENTAL

Drug: IBI362; Drug: warfarin; Drug: atorvastatin

metformin+digoxin+IBI362

EXPERIMENTAL

Drug: metformin; Drug: digoxin; Drug: IBI362

Interventions

metformin DRUG

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.

metformin+digoxin+IBI362

digoxin DRUG

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.

metformin+digoxin+IBI362

IBI362 DRUG

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.

metformin+digoxin+IBI362; warfarin+atorvastatin+IBI362

warfarin DRUG

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.

warfarin+atorvastatin+IBI362

atorvastatin DRUG

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.

warfarin+atorvastatin+IBI362

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

MeSH Terms

Interventions

Metformin; Digoxin; mazdutide; Warfarin; Atorvastatin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 18, 2023
• Study Start: April 6, 2023
• Primary Completion: August 18, 2023
• Study Completion: October 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (1)