Skip to main content
OpenTrials
Completed

NCT Number: NCT02815839

Single Dose Study of SHR4640 in Healthy Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gout; Hyperuricemia Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southwest Hospital

Chongqing, Sichuan, 400038, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR4640

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

  3. Half-time (T1/2)

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

  4. Time to the peak plasma concentration (Tmax)

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

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

    Time frame: up to day 11

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

    Time frame: up to day 11

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

    Time frame: up to day 11

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

    Time frame: up to day 11

  9. Changes in serum uric acid concentration from baseline

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

    absolute and percent changes in serum acid concentration

  10. Changes in urinary uric acid excretion from baseline

    Time frame: up to day 4; up to day 11 for 7.5mg dose group

    percent changes in urinary uric acid excretion from baseline

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.