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Multiple Dose Study of SHR4640 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02890966
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

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




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Clinical significant changes from baseline up to Day 10 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890966


Locations
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China, Chongqing
The South West Hospital
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02890966    
Other Study ID Numbers: SHR4640-102
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR4640 pharmacokinetics pharmacodynamics
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes