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

Qingdao University

Status and phase: Unknown; Phase 1

Conditions: Gout

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05324423

XNW3009-I-04

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cohort 1

Other group

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

Treatment:

Drug: Colchicine