Clinical trial NCT02986529: A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Lead sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
timeFrame: 3 days
measure: 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
timeFrame: 3 days
measure: 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)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
state: Shanghai
Study officials:
References: