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

NCT03131583 | Completed Phase 1

• 1 other identifier: SHR4640-103
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Keywords

SHR4640 Febuxostat Colchicine pharmacodynamics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Incidence of Adverse events

  Clinical significant changes from Day-14 up to Day 16

• Changes in Laboratory Values

  Clinical significant changes from Day-14 up to Day 16

• Changes in Electrocardiogram

  Clinical significant changes from Day-14 up to Day 16

• Changes in Vital Signs Parameters

  Clinical significant changes from Day-14 up to Day 16

Study Arms (1)

Cohort 1

EXPERIMENTAL

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; Drug: Febuxostat; Drug: SHR4640

Interventions

Colchicine DRUG

Day-14\~Day16 qd

Cohort 1

Febuxostat DRUG

Day1 and Day8 qd

Cohort 1

SHR4640 DRUG

Day3\~Day8 qd

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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。

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Gout

Interventions

Colchicine; Febuxostat; ruzinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: April 27, 2017
• Study Start: February 17, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)