NCT02890966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

September 1, 2016

Last Update Submit

March 29, 2017

Conditions

Gout; Hyperuricemia

Keywords

SHR4640 pharmacokinetics pharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Clinical significant changes from baseline up to Day 10

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

1mg SHR4640 or placebo

Drug: SHR4640Drug: placebo

Cohort 2

EXPERIMENTAL

2.5mg SHR4640 or placebo

Drug: SHR4640Drug: placebo

Cohort 3

EXPERIMENTAL

5mg SHR4640 or placebo

Drug: SHR4640Drug: placebo

Cohort 4

EXPERIMENTAL

10mg SHR4640 or placebo

Drug: SHR4640Drug: placebo

Interventions

SHR4640DRUG

Day1\~Day7:oral administration

Cohort 1Cohort 2Cohort 3Cohort 4
placeboDRUG

Day1\~Day7:oral administration

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 55, male;
  • Body weight≥50, BMI:19-25kg/m2;
  • mg/dL≤Screening serum urate level≤7 mg/dL;
  • Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The South West Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

CN(1)