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

Sciwind Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Rosuvastatin; Drug: XW003 injection; Drug: Metformin; Drug: Digoxin; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06335134

SCW0502-1016

Details and patient eligibility

About

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

Full 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

Enrollment: 57 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Warfarin

Drug: Metformin

Drug: XW003 injection

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

Experimental group

Description:

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.

Treatment:

Drug: Digoxin

Drug: XW003 injection

Drug: Rosuvastatin