BioavailabilityPhase 1NCT02986529
A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects
A Phase 1 study testing GV-971 in people with Bioavailability, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- GV-971
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
Shanghai, Shanghai Municipality, 200031
About this study
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
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
- Being tested
- GV-971, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV-971Drug
Also called Sodium Oligo-mannurarate
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| GV-971 150mg/capsule | Active comparator | 900mg, oral Receives: Drug: GV-971 |
| GV-971 300mg/capsule | Experimental | 900mg, oral Receives: Drug: GV-971 |
| GV-971 450mg/capsule | Experimental | 900mg, oral Receives: Drug: GV-971 |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
Measured: 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
Measured: 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)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion24 Feb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986529
- Sponsor's protocol ID
- CRC-C1503
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02986529
- Acronym / sponsor ID
- CRC-C1503
- Conditions
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GV-971 150mg/capsule | Active comparator | Drug: GV-971900mg, oral |
| GV-971 300mg/capsule | Experimental | Drug: GV-971900mg, oral |
| GV-971 450mg/capsule | Experimental | Drug: GV-971900mg, oral |
| Placebo | Placebo comparator | Drug: PlacebosOral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV-971Also: Sodium Oligo-mannurarate | Drug | GV-971 150mg/capsule, GV-971 300mg/capsule, GV-971 450mg/capsule |
| Placebos | Drug | Placebo |
Primary outcome
Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve
Time frame: 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
Time frame: 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)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GV-971 in people with Bioavailability, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax - maximum observed concentration, is obtained directly from the plasma concentration curve (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.