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To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324423
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
10.4
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Cohort 1

Colchicine 0.5 mg Oral Tablet Day-7~Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8~Day21 qd. Interventions: Drug: Colchicine Drug: Febuxostat Drug: XNW3009

Drug: Colchicine
Colchicine0.5 mg Oral Tablet Day-7~Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd
Other Names:
  • Febuxostat、XNW3009

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Observed maximum concentration at steady state (Cmax,ss) [100 days]

      To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout

    2. Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) [100 days]

      To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout

    Secondary Outcome Measures

    1. Time to Maximum Serum Concentration (Tmax) [100 days]

      To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout

    2. Mean Terminal Phase Half-life (t1/2) [100 days]

      To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients

    3. Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) [100 days]

      Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

    4. Serum or urine Uric Acid Level [100 days]

      Change in Serum or urine Uric Acid Level

    5. Serum or urine Creatinine [100 days]

      Change in Serum or urine Creatinine

    6. Number of Participants With Clinically Significant Laboratory Test Abnormalities [100 days]

      Investigator judged clinical significance of laboratory test abnormalities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subject has a body mass index ≥18.0 and ≤32 kg/m2;

    • Screening sUA value ≥480μmol/L;

    • Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

    Exclusion Criteria:

    • Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr>ULN；

    • History of kidney stones or screening kidney stones by B-ultrasound;

    • History of malignancy；

    • History of xanthinuria；

    • Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood

    • ALT or AST > 1.5 x ULN

    • Unstable angina, history of symptomatic arrhythmia, or heart failure

    • HbAlc>8%

    • eGFR<60ml/min/1.73m2

    • Investigational drug within 3 months of study dosing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266003

    Sponsors and Collaborators

    • The Affiliated Hospital of Qingdao University

    Investigators

    • Principal Investigator: Yi Xu, Doctor, The Affiliated Hospital of Qingdao University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Affiliated Hospital of Qingdao University
    ClinicalTrials.gov Identifier:
    NCT05324423
    Other Study ID Numbers:
    • XNW3009-I-04
    First Posted:
    Apr 12, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gout
    Colchicine
    Febuxostat

    Study Results

    No Results Posted as of May 9, 2022