Multiple Dose Study of SHR4640 in Healthy Subjects

Gout; Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890966
• Other study ID #: SHR4640-102
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2016
• Last updated: March 29, 2017
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• 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 tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 55, male;

2. Body weight=50, BMI:19-25kg/m2;

3.4 mg/dL=Screening serum urate level=7 mg/dL;

4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

Exclusion Criteria:

1. Serum creatinine>upper limits of normal(ULN);

2. Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;

3. History of hyperuricemia or gout;

4. History or suspicion of kidney stones;

5. Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Related Conditions & MeSH terms

• Gout; Hyperuricemia
• Hyperuricemia

Intervention

Drug:
• SHR4640
Day1~Day7:oral administration
• placebo
Day1~Day7:oral administration

Locations

Country	Name	City	State
China	The South West Hospital	Chongqing	Chongqing

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 Day 10
Secondary	Peak Plasma Concentration(Cmax)(of single dose and at stable status)		Up to Day 10
Secondary	Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)		Up to Day 10
Secondary	Half-time(T1/2)(of single dose and at stable status)		Up to Day 10
Secondary	Time to the peak plasma concentration(Tmax)(of single dose and at stable status)		Up to Day 10
Secondary	Changes in serum uric acid concentration from baseline		Up to Day 10
Secondary	Changes in urinary uric acid excretion from baseline		Up to Day 10