Single Dose Study of SHR4640 in Healthy Subjects

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02815839

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 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 Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 2.5-mg SHR4640 or placebo	Drug: SHR4640 Drug: Placebo
Experimental: Cohort 2 5-mg SHR4640 or placebo	Drug: SHR4640 Drug: Placebo
Experimental: Cohort 3 7.5-mg SHR4640 or placebo	Drug: SHR4640 Drug: Placebo
Experimental: Cohort 4 10-mg SHR4640 or placebo	Drug: SHR4640 Drug: Placebo
Experimental: Cohort 5 20-mg SHR4640 or placebo	Drug: SHR4640 Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) [up to day 4; up to day 11 for 7.5mg dose group]
Area under the plasma concentration versus time curve (AUC) [up to day 4; up to day 11 for 7.5mg dose group]
Half-time (T1/2) [up to day 4; up to day 11 for 7.5mg dose group]
Time to the peak plasma concentration (Tmax) [up to day 4; up to day 11 for 7.5mg dose group]
Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group [up to day 11]
AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group [up to day 11]
T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group [up to day 11]
Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group [up to day 11]
Changes in serum uric acid concentration from baseline [up to day 4; up to day 11 for 7.5mg dose group]
absolute and percent changes in serum acid concentration
Changes in urinary uric acid excretion from baseline [up to day 4; up to day 11 for 7.5mg dose group]
percent changes in urinary uric acid excretion from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.