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

NCT05324423 | Unknown Phase 1 DMC

• 1 other identifier: XNW3009-I-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Time to Maximum Serum Concentration (Tmax)

  100 days

• Mean Terminal Phase Half-life (t1/2)

  100 days

• Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

  100 days

• Serum or urine Uric Acid Level

  100 days

• Serum or urine Creatinine

  100 days

Study Arms (1)

Cohort 1

OTHER

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

Interventions

Colchicine DRUG

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

Also known as: Febuxostat、XNW3009

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

MeSH Terms

Conditions

Gout

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Yi Xu, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, Doctor

CONTACT

18661809090; caoyu1767@126.com

Yi Xu, Doctor

CONTACT

18661809455; xuyi198861@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: April 12, 2022
• Study Start: October 18, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)