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

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ClinicalTrials.gov Identifier: NCT03131583
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Gout Drug: Colchicine Drug: Febuxostat Drug: SHR4640 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Drug Reactions Gout

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




Primary Outcome Measures :
  1. Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]
    PK profile

  2. Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]
    PK profile

  3. Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma [ Time Frame: Clinical significant changes from baseline up to Day 8 ]
    PK profile


Secondary Outcome Measures :
  1. Incidence of Adverse events [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]
    Safety issue

  2. Changes in Laboratory Values [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]
    Safety issue

  3. Changes in Electrocardiogram [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]
    Safety issue

  4. Changes in Vital Signs Parameters [ Time Frame: Clinical significant changes from Day-14 up to Day 16 ]
    Safety issue



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has a body mass index ≥18.5 and ≤30 kg/m2;
  2. Screening sUA value ≥8 and ≤10 mg/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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131583


Contacts
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Contact: Liyan Miao 18915505252 miaolysuzhou@163.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Liyan Miao    18915505252    miaolysuzhou@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03131583     History of Changes
Other Study ID Numbers: SHR4640-103
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR4640 Febuxostat Colchicine pharmacodynamics

Additional relevant MeSH terms:
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Febuxostat
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents