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Completed

NCT Number: NCT03131583

The Drug-Drug Interaction of SHR4640, Febuxostat 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has a body mass index ≥18.5 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.

Exclusion criteria

  • Subject known or suspected of being sensitive to the study drugs or its ingredient;
  • sCr>ULN;
  • History of kidney stones or screening kidney stones by B-ultrasound;
  • History of malignancy within 5 years;
  • History of xanthinuria;
  • Donated blood(≥400ml)within 3 months prior to screening or received transfusion of blood。

Treatment and study plan

Colchicine

Drug

Day-14~Day16 qd

Febuxostat

Drug

Day1 and Day8 qd

SHR4640

Drug

Day3~Day8 qd

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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