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

A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

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

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: Colchicine

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Cao, Doctor; Phone Number: 18661809090; Email: Caoyu1767@126.com
• Study Contact Backup: Name: Yi Xu, Doctor; Phone Number: 18661809455; Email: xuyi198861@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Yu Cao, Doctor; Phone Number: 18661809090; Email: Caoyu1767@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; 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	Drug: Colchicine; 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; Other Names: Febuxostat、XNW3009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed maximum concentration at steady state (Cmax,ss)	To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout	100 days
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)	To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout	100 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Yi Xu, Doctor, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine; Febuxostat
• Other Study ID Numbers: XNW3009-I-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No