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

A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout

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

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Colchicine; Drug: Febuxostat; Drug: SHR4640

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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.	Drug: Colchicine; Day-14~Day16 qd; Drug: Febuxostat; Day1 and Day8 qd; Drug: SHR4640; Day3~Day8 qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma	PK profile	Clinical significant changes from baseline up to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse events	Safety issue	Clinical significant changes from Day-14 up to Day 16
Changes in Laboratory Values	Safety issue	Clinical significant changes from Day-14 up to Day 16
Changes in Electrocardiogram	Safety issue	Clinical significant changes from Day-14 up to Day 16
Changes in Vital Signs Parameters	Safety issue	Clinical significant changes from Day-14 up to Day 16

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): January 29, 2018
• Study Completion (Actual): January 29, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

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

More Information

Terms related to this study

• Keywords: SHR4640 Febuxostat Colchicine pharmacodynamics
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine; Febuxostat
• Other Study ID Numbers: SHR4640-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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