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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: Febuxostat; Drug: Colchicine; Drug: SHR4640

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131583

SHR4640-103

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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。

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: SHR4640

Drug: Febuxostat

Drug: Colchicine