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Completed

NCT Number: NCT02890966

Multiple Dose Study of SHR4640 in Healthy Subjects

The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.

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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–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The South West Hospital

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 and 55, male;
  • Body weight≥50, BMI:19-25kg/m2;

3.4 mg/dL≤Screening serum urate level≤7 mg/dL;

4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

Exclusion criteria

  • Serum creatinine>upper limits of normal(ULN);
  • Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
  • History of hyperuricemia or gout;
  • History or suspicion of kidney stones;
  • Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Treatment and study plan

SHR4640

Drug

Day1~Day7:oral administration

Placebo

Drug

Day1~Day7:oral administration

Primary outcomes

  1. Adverse events

    Time frame: Clinical significant changes from baseline up to Day 10

Secondary outcomes

  1. Peak Plasma Concentration(Cmax)(of single dose and at stable status)

    Time frame: Up to Day 10

  2. Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)

    Time frame: Up to Day 10

  3. Half-time(T1/2)(of single dose and at stable status)

    Time frame: Up to Day 10

  4. Time to the peak plasma concentration(Tmax)(of single dose and at stable status)

    Time frame: Up to Day 10

  5. Changes in serum uric acid concentration from baseline

    Time frame: Up to Day 10

  6. Changes in urinary uric acid excretion from baseline

    Time frame: Up to Day 10

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 Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2016
Registry last updated
Mar 30, 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.

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