Status:
UNKNOWN
To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Gout
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05324423
Start Date
October 18 2021
End Date
September 1 2022
Last Update
May 9 2022
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003