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

NCT ID: NCT06335134

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-14
• Study Completion Date: 2024-06-28

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment

Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.

Group Type: EXPERIMENTAL

XW003 injection

Intervention Type: DRUG

Administered subcutaneously

Metformin

Intervention Type: DRUG

Administered orally

Warfarin

Intervention Type: DRUG

Administered orally

Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment

Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.

Group Type: EXPERIMENTAL

XW003 injection

Intervention Type: DRUG

Administered subcutaneously

Rosuvastatin

Intervention Type: DRUG

Administered orally

Digoxin

Intervention Type: DRUG

Administered orally

Interventions

XW003 injection

Administered subcutaneously

Intervention Type: DRUG

Metformin

Administered orally

Intervention Type: DRUG

Warfarin

Administered orally

Intervention Type: DRUG

Rosuvastatin

Administered orally

Intervention Type: DRUG

Digoxin

Administered orally

Intervention Type: DRUG

Other Intervention Names

ecnoglutide

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qin Yu

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Locations

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SCW0502-1016

Identifier Type: -

Identifier Source: org_study_id