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

Phase 1

Completed

• Conditions: Gout
• Interventions: Drug: Colchicine; Drug: Febuxostat; Drug: SHR4640

• Registration Number: NCT03131583
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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。

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Colchicine	Colchicine 0.5 mg Oral Tablet Day-14\~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3\~Day8 qd.
Cohort 1	SHR4640	Colchicine 0.5 mg Oral Tablet Day-14\~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3\~Day8 qd.
Cohort 1	Febuxostat	Colchicine 0.5 mg Oral Tablet Day-14\~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3\~Day8 qd.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Changes in Vital Signs Parameters	Clinical significant changes from Day-14 up to Day 16	Safety issue
Incidence of Adverse events	Clinical significant changes from Day-14 up to Day 16	Safety issue

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China