The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Hyperuricemia

Treatments: Drug: SHR4640 dose1; Drug: Febuxostat dose2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04157959

SHR4640-104

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a body mass index ≥18 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. ALT、AST、TBIL>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy；
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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

SHR4640

Experimental group

Description:

SHR4640 dose1 Oral Tablet Day1\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.

Treatment:

Drug: SHR4640 dose1

Drug: Febuxostat dose2

Febuxostat

Experimental group

Description:

Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\~Day14 qd.

Treatment:

Drug: SHR4640 dose1

Drug: Febuxostat dose2