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

NCT ID: NCT02986529

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GV-971 150mg/capsule

900mg, oral

Group Type: ACTIVE_COMPARATOR

GV-971

Intervention Type: DRUG

GV-971 300mg/capsule

900mg, oral

Group Type: EXPERIMENTAL

GV-971

Intervention Type: DRUG

GV-971 450mg/capsule

900mg, oral

Group Type: EXPERIMENTAL

GV-971

Intervention Type: DRUG

Placebo

Oral

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Interventions

GV-971

Intervention Type: DRUG

Placebos

Intervention Type: DRUG

Other Intervention Names

Sodium Oligo-mannurarate

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Greenvalley Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CRC-C1503

Identifier Type: -

Identifier Source: org_study_id