Single Dose Study of SHR4640 in Healthy Subjects

NCT02815839 | Completed Phase 1

• 1 other identifier: SHR4640-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Hyperuricemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

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

Secondary Outcomes (10)

• 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

Study Arms (5)

Cohort 1

EXPERIMENTAL

2.5-mg SHR4640 or placebo

Drug: SHR4640; Drug: Placebo

Cohort 2

EXPERIMENTAL

5-mg SHR4640 or placebo

Drug: SHR4640; Drug: Placebo

Cohort 3

EXPERIMENTAL

7.5-mg SHR4640 or placebo

Drug: SHR4640; Drug: Placebo

Cohort 4

EXPERIMENTAL

10-mg SHR4640 or placebo

Drug: SHR4640; Drug: Placebo

Cohort 5

EXPERIMENTAL

20-mg SHR4640 or placebo

Drug: SHR4640; Drug: Placebo

Interventions

SHR4640 DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Southwest Hospital

Chongqing, Sichuan, 400038, China

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological 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: April 27, 2016
• First Posted: June 28, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 28, 2017

Record last verified: 2016-06

Locations

CN (1)