Healthy Volunteers
Conditions
Keywords
Ecnoglutide, XW003, Metformin, Warfarin, Rosuvastatin, Digoxin
Brief summary
This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Detailed description
This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group
Interventions
DRUGXW003 injection
Administered subcutaneously
DRUGMetformin
Administered orally
DRUGWarfarin
Administered orally
DRUGRosuvastatin
Administered orally
DRUGDigoxin
Administered orally
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, 18-45 years old, inclusive; 2. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg. 3. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.
Exclusion criteria
1. Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases); 2. History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin; 3. Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption; 4. History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion; 5. History of acute or chronic pancreatitis; 6. History of documented or suspected hypoglycemic episodes within 6 months prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of metformin: AUC0-inf | up to 101 days |
| Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf | up to 114 days |
| Pharmacokinetics of rosuvastatin: AUC0-inf | up to 102 days |
| Pharmacokinetics of digoxin: AUC0-inf | up to 112days |
Countries
China
Outcome results
None listed