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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: XW003 injection; Drug: Rosuvastatin; Drug: Metformin; Drug: Warfarin; Drug: Digoxin

• Registration Number: NCT06335134
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-14
• Study First Submitted: 2023-07-29
• Primary Completion: 2024-01-08
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-28
• Study Completion: 2024-06-28
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment	Rosuvastatin	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.
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment	XW003 injection	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.
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment	XW003 injection	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.
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment	Metformin	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.
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment	Warfarin	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.
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment	Digoxin	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China