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Completed

NCT Number: NCT02356224

The PK/PD Study of Single 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 single-dose study the investigators evaluated the safety, tolerablity 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, 200031, 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 acception of blood transfusion within 8 weeks.

Treatment and study plan

SHR3824

Drug

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.

Other names: Henagliflozin

Placebo

Drug

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.

Primary outcomes

  1. Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.

    Time frame: 24h after dosing

  2. SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.

    Time frame: Up to 72h after dosing

Secondary outcomes

  1. The number of patients with adverse events as a measure of safety and tolerability

    Time frame: up to day 72h after dosing

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: SHR3824

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2015
Registry last updated
Feb 5, 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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