Back to resultsThe Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
Primary Purpose
Hyperuricemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR4640 dose1
Febuxostat dose2
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility Criteria
Inclusion Criteria:
- Subject has a body mass index ≥18 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion Criteria:
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- ALT、AST、TBIL>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。
Sites / Locations
- The Affiliated Hospital of QingDao UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHR4640
Febuxostat
Arm Description
SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
Secondary Outcome Measures
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Full Information
NCT ID
NCT04157959
First Posted
November 4, 2019
Last Updated
November 6, 2019
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04157959
Brief Title
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
Official Title
A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR4640
Arm Type
Experimental
Arm Description
SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
Arm Title
Febuxostat
Arm Type
Experimental
Arm Description
Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.
Intervention Type
Drug
Intervention Name(s)
SHR4640 dose1
Intervention Description
Tablet,dose1,QD
Intervention Type
Drug
Intervention Name(s)
Febuxostat dose2
Intervention Description
Tablet,dose2,QD
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
Time Frame
Day1 to Day 14
Title
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
Time Frame
Day1 to Day 14
Secondary Outcome Measure Information:
Title
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
Time Frame
Day1 to Day 14
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Description
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Time Frame
Clinical significant changes from Day-21 up to Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has a body mass index ≥18 and ≤30 kg/m2;
Screening sUA value ≥8mg/dl;
Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion Criteria:
Subject known or suspected of being sensitive to the study drugs or its ingredient；
ALT、AST、TBIL>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。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cao Yu
Phone
0532-82911767
Email
Caoyu1767@126.com
Facility Information:
Facility Name
The Affiliated Hospital of QingDao University
City
Qingdao
State/Province
Shan Dong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cao Yu
Phone
0532-82911767
Email
Caoyu1767@126.com
12. IPD Sharing Statement
Learn more about this trial
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
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