The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia

Phase 1

• Conditions: Hyperuricemia
• Interventions: Drug: SHR4640 dose1; Drug: Febuxostat dose2

• Registration Number: NCT04157959
• 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 and Febuxostat interaction in patients with Hyperuricemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-14
• Status Verified: 2019-11
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Subject has a body mass index ≥18 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. ALT、AST、TBIL>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy；
5. History of xanthinuria；
6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHR4640	SHR4640 dose1	SHR4640 dose1 Oral Tablet Day1\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
SHR4640	Febuxostat dose2	SHR4640 dose1 Oral Tablet Day1\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
Febuxostat	SHR4640 dose1	Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\~Day14 qd.
Febuxostat	Febuxostat dose2	Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\~Day14 qd.

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma	Day1 to Day 14
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma	Day1 to Day 14

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events	Clinical significant changes from Day-21 up to Day 29	Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma	Day1 to Day 14

Trial Locations

Locations (1)

The Affiliated Hospital of QingDao University; 🇨🇳 Qingdao, Shan Dong, China