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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131583
• Other study ID #: SHR4640-103
• Status: Completed
• Phase: Phase 1
• Start date: February 17, 2017
• Est. completion date: January 29, 2018

Study information

• Verified date: August 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 29, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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?

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Colchicine
Day-14~Day16 qd
• Febuxostat
Day1 and Day8 qd
• SHR4640
Day3~Day8 qd

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8
Primary	Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8
Primary	Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8
Secondary	Incidence of Adverse events	Safety issue	Clinical significant changes from Day-14 up to Day 16
Secondary	Changes in Laboratory Values	Safety issue	Clinical significant changes from Day-14 up to Day 16
Secondary	Changes in Electrocardiogram	Safety issue	Clinical significant changes from Day-14 up to Day 16
Secondary	Changes in Vital Signs Parameters	Safety issue	Clinical significant changes from Day-14 up to Day 16