The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedNovember 8, 2019
November 1, 2019
8 months
November 4, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
Day1 to Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Clinical significant changes from Day-21 up to Day 29
Study Arms (2)
SHR4640
EXPERIMENTALSHR4640 dose1 Oral Tablet Day1\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
Febuxostat
EXPERIMENTALFebuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\~Day14 qd.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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。
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of QingDao University
Qingdao, Shandong, China
Related Publications (1)
Wang C, Yu Q, Jiang X, Deng Y, Sun F, Li X, Tao Y, Lin P, Ma Y, Zhu Y, Li C, Cao Y. A Drug-Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia. J Clin Pharmacol. 2023 Feb;63(2):239-249. doi: 10.1002/jcph.2159. Epub 2022 Oct 20.
PMID: 36131360DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 8, 2019
Study Start
October 14, 2019
Primary Completion
June 1, 2020
Study Completion
June 30, 2020
Last Updated
November 8, 2019
Record last verified: 2019-11