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Single Dose Study of SHR4640 in Healthy Subjects

NCT ID: NCT02815839

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gout; Hyperuricemia

Keywords

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urate transporter 1 SHR4640 single ascending dose pharmacokinetics pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

2.5-mg SHR4640 or placebo

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2

5-mg SHR4640 or placebo

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 3

7.5-mg SHR4640 or placebo

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 4

10-mg SHR4640 or placebo

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 5

20-mg SHR4640 or placebo

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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SHR4640

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwest Hospital

Chongqing, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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SHR4640-101

Identifier Type: -

Identifier Source: org_study_id