Overview

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

Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
Summary
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Treatments:
Colchicine
Febuxostat
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