Multiple Dose Study of SHR4640 in Healthy Subjects

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02890966

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gout; Hyperuricemia	Drug: SHR4640 Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 1mg SHR4640 or placebo	Drug: SHR4640 Day1~Day7:oral administration Drug: placebo Day1~Day7:oral administration
Experimental: Cohort 2 2.5mg SHR4640 or placebo	Drug: SHR4640 Day1~Day7:oral administration Drug: placebo Day1~Day7:oral administration
Experimental: Cohort 3 5mg SHR4640 or placebo	Drug: SHR4640 Day1~Day7:oral administration Drug: placebo Day1~Day7:oral administration
Experimental: Cohort 4 10mg SHR4640 or placebo	Drug: SHR4640 Day1~Day7:oral administration Drug: placebo Day1~Day7:oral administration

Outcome Measures

Primary Outcome Measures

Adverse events [Clinical significant changes from baseline up to Day 10]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 18 and 55, male;
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:

Serum creatinine>upper limits of normal(ULN);
Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
History of hyperuricemia or gout;
History or suspicion of kidney stones;
Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The South West Hospital	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02890966

Other Study ID Numbers:

SHR4640-102

First Posted:

Sep 7, 2016

Last Update Posted:

Mar 30, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.

SHR4640 pharmacokinetics pharmacodynamics

Additional relevant MeSH terms:

Hyperuricemia

Study Results

No Results Posted as of Mar 30, 2017