Single Dose Study of SHR4640 in Healthy Subjects

Gout; Hyperuricemia Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815839
• Other study ID #: SHR4640-101
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2016
• Last updated: February 26, 2017
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: June 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body weight=50, BMI:19-24kg/m2;

• Screening serum urate level = 4.5 mg/dL for male and = 3.5 mg/dL for female;

• Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;

Exclusion Criteria:

• History of hyperuricemia or gout.

• Pregnancy or breastfeeding;

• History or suspicion of kidney stones;

• serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;

• alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.

Related Conditions & MeSH terms

• Gout; Hyperuricemia
• Hyperuricemia

Intervention

Drug:
• SHR4640

• Placebo

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
Secondary	Peak Plasma Concentration (Cmax)		up to day 4; up to day 11 for 7.5mg dose group
Secondary	Area under the plasma concentration versus time curve (AUC)		up to day 4; up to day 11 for 7.5mg dose group
Secondary	Half-time (T1/2)		up to day 4; up to day 11 for 7.5mg dose group
Secondary	Time to the peak plasma concentration (Tmax)		up to day 4; up to day 11 for 7.5mg dose group
Secondary	Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group		up to day 11
Secondary	AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group		up to day 11
Secondary	T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group		up to day 11
Secondary	Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group		up to day 11
Secondary	Changes in serum uric acid concentration from baseline	absolute and percent changes in serum acid concentration	up to day 4; up to day 11 for 7.5mg dose group
Secondary	Changes in urinary uric acid excretion from baseline	percent changes in urinary uric acid excretion from baseline	up to day 4; up to day 11 for 7.5mg dose group