Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986529
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: GV-971 Drug: Placebos Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : November 2016
Actual Primary Completion Date : February 24, 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Active Comparator: GV-971 150mg/capsule
900mg, oral
Drug: GV-971
Other Name: Sodium Oligo-mannurarate

Experimental: GV-971 300mg/capsule
900mg, oral
Drug: GV-971
Other Name: Sodium Oligo-mannurarate

Experimental: GV-971 450mg/capsule
900mg, oral
Drug: GV-971
Other Name: Sodium Oligo-mannurarate

Placebo Comparator: Placebo
Oral
Drug: Placebos



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects;
  2. Age:≥18 and ≤45 on the date signing informed consent
  3. Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg;
  4. 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"::

  1. Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
  2. Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination
  3. Positive serology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test.
  4. Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening
  5. 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;
  6. Serious infection, trauma and major surgery within 4weeks prior to screening;
  7. 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 ;
  8. 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.
  9. Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening;
  10. Vegetarian or person with dietary restrictions
  11. 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.
  12. 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 );
  13. Subjects may be allergic to GV-971 in the opinion of the investigator.
  14. Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986529


Locations
Layout table for location information
China, Shanghai
Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02986529     History of Changes
Other Study ID Numbers: CRC-C1503
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: December 2017