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

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

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Drug: Placebos; Drug: GV-971

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral	Drug: Placebos
Active Comparator: GV-971 150mg/capsule; 900mg, oral	Drug: GV-971; Other Names: Sodium Oligo-mannurarate
Experimental: GV-971 300mg/capsule; 900mg, oral	Drug: GV-971; Other Names: Sodium Oligo-mannurarate
Experimental: GV-971 450mg/capsule; 900mg, oral	Drug: GV-971; Other Names: Sodium Oligo-mannurarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve	3 days
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
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)	3 days

Collaborators and Investigators

• Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): February 24, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CRC-C1503