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

Gout Clinical Trial

Official title:

A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324423
• Other study ID #: XNW3009-I-04
• Status: Recruiting
• Phase: Phase 1
• Start date: October 18, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yu Cao, Doctor
• Phone: 18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	100 days
Primary	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	100 days
Secondary	Time to Maximum Serum Concentration (Tmax)	To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout	100 days
Secondary	Mean Terminal Phase Half-life (t1/2)	To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients	100 days
Secondary	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.	100 days
Secondary	Serum or urine Uric Acid Level	Change in Serum or urine Uric Acid Level	100 days
Secondary	Serum or urine Creatinine	Change in Serum or urine Creatinine	100 days
Secondary	Number of Participants With Clinically Significant Laboratory Test Abnormalities	Investigator judged clinical significance of laboratory test abnormalities.	100 days