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

Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986529
• Other study ID #: CRC-C1503
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2016
• Last updated: February 6, 2018
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2017
• Est. primary completion date: February 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• GV-971

• Placebos

Locations

Country	Name	City	State
China	Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve		3 days
Primary	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		3 days
Primary	AUC0-8-the area under the concentration-time curve from zero to the infinity, computed as AUC0-8=AUC0-last+Clast/?z (?z is the terminal phase rate constant)		3 days