Skip to main content
OpenTrials
Completed

NCT Number: NCT05815680

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Maximum observed metformin plasma concentration at steady state

    Time frame: up to 116 days

  2. Area under the metformin plasma concentration-time curve

    Time frame: up to 116 days

  3. Maximum observed warfarin plasma concentration at steady state

    Time frame: up to 116 days

  4. Area under the warfarin plasma concentration-time curve

    Time frame: up to 116 days

  5. Maximum observed atorvastatin plasma concentration at steady state

    Time frame: up to 116 days

  6. Area under the atorvastatin plasma concentration-time curve

    Time frame: up to 116 days

  7. Maximum observed digoxin plasma concentration at steady state

    Time frame: up to 116 days

  8. Area under the digoxin plasma concentration-time curve

    Time frame: up to 116 days

Secondary outcomes

  1. Actual adverse events

    Time frame: up to 116 days

  2. Terminal elimination half-life

    Time frame: up to 116 days

  3. time to maximum plasma concentration of IBI362

    Time frame: up to 116 days

  4. Incremental area under the INR (international normalised ratio) -curve of warfarin

    Time frame: up to 116 days

  5. Total apparent clearance of IBI362

    Time frame: up to 116 days

  6. Apparent volume of distribution of IBI362

    Time frame: up to 116 days

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.