The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03131583

Enrollment

Registered

2017-04-27

Start date

2017-02-17

Completion date

2018-01-29

Last updated

2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

SHR4640 Febuxostat Colchicine pharmacodynamics

Brief summary

The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.

Interventions

DRUGColchicine

Day-14\ Day16 qd

DRUGFebuxostat

Day1 and Day8 qd

DRUGSHR4640

Day3\ Day8 qd

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Subject has a body mass index ≥18.5 and ≤30 kg/m2; 2. Screening sUA value ≥8mg/dl; 3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion criteria

1. Subject known or suspected of being sensitive to the study drugs or its ingredient； 2. sCr\>ULN; 3. History of kidney stones or screening kidney stones by B-ultrasound； 4. History of malignancy within 5 years； 5. History of xanthinuria； 6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Design outcomes

Primary

Measure	Time frame	Description
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma	Clinical significant changes from baseline up to Day 8	PK profile
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma	Clinical significant changes from baseline up to Day 8	PK profile
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma	Clinical significant changes from baseline up to Day 8	PK profile

Secondary

Measure	Time frame	Description
Incidence of Adverse events	Clinical significant changes from Day-14 up to Day 16	Safety issue
Changes in Vital Signs Parameters	Clinical significant changes from Day-14 up to Day 16	Safety issue
Changes in Laboratory Values	Clinical significant changes from Day-14 up to Day 16	Safety issue
Changes in Electrocardiogram	Clinical significant changes from Day-14 up to Day 16	Safety issue

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026