Gout
Conditions
Brief summary
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
Interventions
DRUGColchicine
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
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Uric Acid Level | 100 days | Change in Serum or urine Uric Acid Level |
| Time to Maximum Serum Concentration (Tmax) | 100 days | To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | 100 days | Investigator judged clinical significance of laboratory test abnormalities. |
| Serum or urine Creatinine | 100 days | Change in Serum or urine Creatinine |
| Mean Terminal Phase Half-life (t1/2) | 100 days | To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients |
Countries
China
Contacts
Primary ContactYu Cao, Doctor
Backup ContactYi Xu, Doctor
Outcome results
None listed