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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03131583
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
11.4
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
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 :
Feb 17, 2017
Actual Primary Completion Date :
Jan 29, 2018
Actual Study Completion Date :
Jan 29, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma [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 [Clinical significant changes from baseline up to Day 8]

    PK profile

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

    PK profile

Secondary Outcome Measures

  1. Incidence of Adverse events [Clinical significant changes from Day-14 up to Day 16]

    Safety issue

  2. Changes in Laboratory Values [Clinical significant changes from Day-14 up to Day 16]

    Safety issue

  3. Changes in Electrocardiogram [Clinical significant changes from Day-14 up to Day 16]

    Safety issue

  4. Changes in Vital Signs Parameters [Clinical significant changes from Day-14 up to Day 16]

    Safety issue

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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。

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03131583
Other Study ID Numbers:
  • SHR4640-103
First Posted:
Apr 27, 2017
Last Update Posted:
Aug 8, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Gout
Colchicine
Febuxostat

Study Results

No Results Posted as of Aug 8, 2019