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

Last updated: March 25, 2024
Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Digoxin

Metformin

Rosuvastatin

Clinical Study ID

NCT06335134
SCW0502-1016
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Presence of clinically significant conditions (including but not limited torespiratory 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 ofsensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
  3. Known difficulty in swallowing tablets or history of gastrointestinal diseasesaffecting 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 toscreening;

Study Design

Total Participants: 56
Treatment Group(s): 5
Primary Treatment: Digoxin
Phase: 1
Study Start date:
July 14, 2023
Estimated Completion Date:
March 31, 2024

Study 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

Connect with a study center

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

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