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

Primary Purpose

Gout

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Colchicine
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort 1

Arm Description

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

Outcomes

Primary Outcome Measures

Observed maximum concentration at steady state (Cmax,ss)
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout

Secondary Outcome Measures

Time to Maximum Serum Concentration (Tmax)
To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout
Mean Terminal Phase Half-life (t1/2)
To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
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.
Serum or urine Uric Acid Level
Change in Serum or urine Uric Acid Level
Serum or urine Creatinine
Change in Serum or urine Creatinine
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Investigator judged clinical significance of laboratory test abnormalities.

Full Information

First Posted
December 12, 2021
Last Updated
May 6, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05324423
Brief Title
To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Official Title
A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Febuxostat、XNW3009
Intervention Description
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
Primary Outcome Measure Information:
Title
Observed maximum concentration at steady state (Cmax,ss)
Description
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Time Frame
100 days
Title
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Description
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Time to Maximum Serum Concentration (Tmax)
Description
To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout
Time Frame
100 days
Title
Mean Terminal Phase Half-life (t1/2)
Description
To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients
Time Frame
100 days
Title
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Description
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.
Time Frame
100 days
Title
Serum or urine Uric Acid Level
Description
Change in Serum or urine Uric Acid Level
Time Frame
100 days
Title
Serum or urine Creatinine
Description
Change in Serum or urine Creatinine
Time Frame
100 days
Title
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Description
Investigator judged clinical significance of laboratory test abnormalities.
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Cao, Doctor
Phone
18661809090
Email
caoyu1767@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Xu, Doctor
Phone
18661809455
Email
xuyi198861@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Xu, Doctor
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Cao, Doctor
Phone
18661809090
Email
caoyu1767@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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