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

The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: SHR4640 dose1; Drug: Febuxostat dose2

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shan Dong
    • Qingdao, Shan Dong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Cao Yu; Phone Number: 0532-82911767; Email: Caoyu1767@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR4640; SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.	Drug: SHR4640 dose1; Tablet,dose1,QD; Drug: Febuxostat dose2; Tablet,dose2,QD
EXPERIMENTAL: Febuxostat; Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.	Drug: SHR4640 dose1; Tablet,dose1,QD; Drug: Febuxostat dose2; Tablet,dose2,QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.	Clinical significant changes from Day-21 up to Day 29

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (ACTUAL): November 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: SHR4640-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No