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Single Dose Study of SHR4640 in Healthy Subjects

Primary Purpose

Gout; Hyperuricemia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR4640

Placebo

About this trial

This is an interventional treatment trial for Gout; Hyperuricemia focused on measuring urate transporter 1, SHR4640, single ascending dose, pharmacokinetics, pharmacodynamics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

2.5-mg SHR4640 or placebo

5-mg SHR4640 or placebo

7.5-mg SHR4640 or placebo

10-mg SHR4640 or placebo

20-mg SHR4640 or placebo

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Half-time (T1/2)

Time to the peak plasma concentration (Tmax)

Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group

AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group

T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group

Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group

Changes in serum uric acid concentration from baseline

absolute and percent changes in serum acid concentration

Changes in urinary uric acid excretion from baseline

percent changes in urinary uric acid excretion from baseline

Full Information

NCT ID

NCT02815839

First Posted

April 27, 2016

Last Updated

February 26, 2017

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02815839

Brief Title

Single Dose Study of SHR4640 in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout; Hyperuricemia

Keywords

urate transporter 1, SHR4640, single ascending dose, pharmacokinetics, pharmacodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

2.5-mg SHR4640 or placebo

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

5-mg SHR4640 or placebo

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

7.5-mg SHR4640 or placebo

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

10-mg SHR4640 or placebo

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

20-mg SHR4640 or placebo

Intervention Type

Drug

Intervention Name(s)

SHR4640

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group

Secondary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax)

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

Title

Area under the plasma concentration versus time curve (AUC)

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

Title

Half-time (T1/2)

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

Title

Time to the peak plasma concentration (Tmax)

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

Title

Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group

Time Frame

up to day 11

Title

AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group

Time Frame

up to day 11

Title

T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group

Time Frame

up to day 11

Title

Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group

Time Frame

up to day 11

Title

Changes in serum uric acid concentration from baseline

Description

absolute and percent changes in serum acid concentration

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

Title

Changes in urinary uric acid excretion from baseline

Description

percent changes in urinary uric acid excretion from baseline

Time Frame

up to day 4; up to day 11 for 7.5mg dose group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Southwest Hospital

City

Chongqing

State/Province

Sichuan

ZIP/Postal Code

400038

Country

China

12. IPD Sharing Statement

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Single Dose Study of SHR4640 in Healthy Subjects

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