A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

Healthy Volunteers Clinical Trial

Official title:

A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335134
• Other study ID #: SCW0502-1016
• Status: Recruiting
• Phase: Phase 1
• Start date: July 14, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: Hangzhou Sciwind Biosciences Co., Ltd.
• Contact: Guan Lei
• Phone: +8618910900897
• Email: lei.guan[@]sciwindbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 31, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• XW003 injection
Administered subcutaneously
• Metformin
Administered orally
• Warfarin
Administered orally
• Rosuvastatin
Administered orally
• Digoxin
Administered orally

Locations

Country	Name	City	State
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of metformin: AUC0-inf		up to 101 days
Primary	Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf		up to 114 days
Primary	Pharmacokinetics of rosuvastatin: AUC0-inf		up to 102 days
Primary	Pharmacokinetics of digoxin: AUC0-inf		up to 112days