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

Phase 1

• Conditions: Gout
• Interventions: Drug: Colchicine

• Registration Number: NCT05324423
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Colchicine	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

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China