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Completed

NCT Number: NCT02361138

The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Chinese male and female subjects aged 18 to 45 years.
  • BMI:18 -25 kg/m2.
  • Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria

  • History of or current clinically significant medical illness as determined by the Investigator.
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
  • Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
  • Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.

Treatment and study plan

SHR3824

Drug

Other names: Henagliflozin

Placebo

Drug

Primary outcomes

  1. AUC(Area under the curve) of SHR3824.

    Time frame: day1 and day11 to day 13.

  2. Cmax(the maximum concentration) of SHR3824.

    Time frame: day1 and day11 to day 13.

  3. Tmax(the time reaching maximum concentration) of SHR3824.

    Time frame: day1 and day11 to day 13.

  4. Halflife of SHR3824.

    Time frame: day1 and day11 to day 13.

  5. CL/F of SHR3824.

    Time frame: day1 and day11 to day 13.

  6. V/F of SHR3824.

    Time frame: day1 and day11 to day 13.

  7. Accumulation ratio of SHR3824

    Time frame: Up to day 13.

  8. Urine glucose concentration of SHR3824.

    Time frame: day1 and day11

  9. Plasma glucose concentration of SHR3824.

    Time frame: day1 and day11

Secondary outcomes

  1. Adverse events, vital signs, physical exams , ECG, clinical labs

    Time frame: Days -14 to -1, 0, 13.

  2. Serum creatinine

    Time frame: Days -14 to -1, 0, 2, 9, 13.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2015
Registry last updated
Feb 11, 2015

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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