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

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT06335134
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • XW003 injection — DRUG
    Administered subcutaneously
  • Metformin — DRUG
    Administered orally
  • Warfarin — DRUG
    Administered orally
  • Rosuvastatin — DRUG
    Administered orally
  • Digoxin — DRUG
    Administered orally

Study Details

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

Key Dates

Start date
Jul 14, 2023
Status verified
Jul 2023
Primary completion
Jan 8, 2024
Completion
Jun 28, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Pharmacokinetics of metformin: AUC0-inf [ Time Frame: up to 101 days ]

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