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Completed

NCT Number: NCT02986529

A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects

To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after administration of single oral doses of 900mg in healthy Male subjects.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Phase-I Clinical Research Unit at Shanghai Xuhui Center 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

  • Healthy male subjects;
  • Age:≥18 and ≤45 on the date signing informed consent
  • Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg;
  • Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

Exclusion criteria

A subject will be excluded if the answer to any of the following criteria is "yes"::

  • Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
  • Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination
  • Positive serology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test.
  • Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening
  • Participation in any investigational drug or medical instrument study within 3months prior to screening, participation in 3 and more than 3 drug tests in a recent year;
  • Serious infection, trauma and major surgery within 4weeks prior to screening;
  • Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 4 weeks prior to screening, receiving blood transfusion treatment within 8 weeks prior to screening ;
  • Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening.
  • Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening;
  • Vegetarian or person with dietary restrictions
  • Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study.
  • With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to ccardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
  • Subjects may be allergic to GV-971 in the opinion of the investigator.
  • Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.

Treatment and study plan

GV-971

Drug

Other names: Sodium Oligo-mannurarate

Placebos

Drug

Primary outcomes

  1. Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve

    Time frame: 3 days

  2. AUC0-last-the area under the concentration-time curve from zero to the time of the last measurable concentration; computed using the linear trapezoidal rule

    Time frame: 3 days

  3. AUC0-∞-the area under the concentration-time curve from zero to the infinity, computed as AUC0-∞=AUC0-last+Clast/λz (λz is the terminal phase rate constant)

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Double-blind, Randomized, Three-period, Three-way Crossover Design, Placebo Controlled Single Dose Study to Assess the Bioavailability of Sodium Oligo-mannurarate (GV-971) Capsule 150 mg, 300mg, 450mg in Healthy Chinese Male Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Feb 7, 2018

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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