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

Conditions

• Obese Subjects
• Overweight Subjects

Eligibility Criteria

Sex

MALE

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Apr 6, 2023

Status verified

Nov 2023

Primary completion

Aug 18, 2023

Completion

Oct 30, 2023

Study Design

Enrollment

48 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: warfarin+atorvastatin+IBI362
• Experimental: metformin+digoxin+IBI362

Primary Outcome Measure

Maximum observed metformin plasma concentration at steady state [ Time Frame: up to 116 days ]