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

NCT02986529 | Completed Phase 1

• 1 other identifier: CRC-C1503
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

GV-971 150mg/capsule

ACTIVE COMPARATOR

900mg, oral

Drug: GV-971

GV-971 300mg/capsule

EXPERIMENTAL

900mg, oral

Drug: GV-971

GV-971 450mg/capsule

EXPERIMENTAL

900mg, oral

Drug: GV-971

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebos

Interventions

GV-971 DRUG

Also known as: Sodium Oligo-mannurarate

GV-971 150mg/capsule; GV-971 300mg/capsule; GV-971 450mg/capsule

Placebos DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects;
• Age：≥18 and ≤45 on the date signing informed consent
• Body mass index (BMI): 18-25 kg/m2 and the weight ≥50 kg；
• Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Greenvalley Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

GV-971

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: February 24, 2017
• Study Completion: November 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2017-12

Locations

CN (1)