Hyperglycaemia (Diabetic)Phase 1NCT03171623
The Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride
A Phase 1 study testing globalagliatin hydrochloride in people with Hyperglycaemia (Diabetic) and Healthy Volunteers, run by Yabao Pharmaceutical Group at 1 site in China.
Trial summary
This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycaemia (Diabetic), Healthy Volunteers
- What is being tested?
- globalagliatin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to 9 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and females between the ages of 18 and 65 years, inclusive, healthy subjects
- A screening body mass index (BMI) of 18 to 26 kg/m2 inclusive, body weight above 50kg
- FPG≥3.9mmol/L and <6.1 mmol/L
- Have medical history, physical examination, laboratory tests and other relative test results within the normal range or with abnormalities deemed clinically insignificant by the investigator.
- Have given written informed consent.
- The subjects took effective contraceptive measures, and had no birth plan within 3 months.Female subjects should be non lactating, negative pregnancy test, or no fertility potential (Women who were 12 months of menopause or without uterus were found to have no potential for pregnancy )
Who cannot join
- There is a serious history of systemic disease, or a family history (including cardiovascular system, digestive system, urinary system, etc.)
- Have taken a special diet or exercise before 48 hours of drug administration or other factors are capable of significantly altering the absorption, or metabolism or elimination of drugs.
- A significant abnormality in ALT,AST or other lab test results
- Frontal chest X light result is clinical significantly abnormal.
- Have known intolerance of or allergies to glucokinase activators, or related compounds.
- Have known allergies to other compounds or biologic products.
Show all 16Show fewer
- Have a major surgery in the last 4 weeks before dosing.
- To inoculate any live vaccine within 4 weeks before drug administration.
- Have a history of drug abuse
- Use any prescription drugs within 4 weeks prior to administration or use OTC or traditional Chinese medicine within 1 weeks before enrollment.
- Regular drinkers within 6 months before or during the trial (Subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) [1 unit = 360 mL of beer; or 150 mL of wine; or 45 mL of distilled spirits])
- The amount of daily cigarette smoking was more than 5/day in last 3 months, or subjects unwilling to stop cigarette consumption during the trial.
- Are enrolled in 4 or more clinical trials within last year, or participated any clinical trail within 3 months before enrollment ; plan to donate blood or blood donation of 450 mL or more in the last 3 months; or have blood transfusion 4 weeks before the trial.
- An clinical significant abnormality in the 12-lead ECG at screening or baseline: QT interval> 450 ms
- Subjects deemed unsuitable by the Investigator for low compliance or any other reason.
- investigator and their immediate families.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: A Randomised,Double-blind,Placebo-controlled Study to Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride (SY-004) in Chinese Healthy Subjects
This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004).
Read the detailed description
Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is expressed in pancreatic islet beta cells where it acts as a "glucose sensor" for insulin release. Activation of glucokinase increases the glucose sensitivity of insulin secretion, effectively lowering the glucose threshold for insulin secretion. Because of its potential to enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for use as a treatment for hyperglycaemia,glubalagliatin( the active ingredient in SY-004 capsule) is being investigated for use as a treatment for T2DM patients. This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of SY-004 administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of SY-004.
- Conditions
- Hyperglycaemia (Diabetic), Healthy Volunteers
- Being tested
- globalagliatin hydrochloride, placebo
- Keywords
- T2DM, Diabetes, GKA
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
globalagliatin hydrochlorideDrug
Also called SY-004 capsule
orally administration, single dose
placeboDrug
orally administration, single dose
| Study group | Role | What they receive |
|---|---|---|
| SY-004 2mg | Experimental | SY-004 (globalagliatin hydrochloride) 2mg by mouth, single dose Receives: Drug: globalagliatin hydrochloride |
| SY-004 20mg&placebo | Placebo comparator | SY-004 (globalagliatin hydrochloride) 20mg or placebo by mouth, single dose Receives: Drug: globalagliatin hydrochloride; Drug: placebo |
| SY-004 40mg&placebo | Placebo comparator | SY-004 (globalagliatin hydrochloride) 40mg or placebo by mouth, single dose Receives: Drug: globalagliatin hydrochloride; Drug: placebo |
| SY-004 80mg&placebo | Placebo comparator | SY-004 (globalagliatin hydrochloride) 80mg or placebo by mouth, single dose Receives: Drug: globalagliatin hydrochloride; Drug: placebo |
| SY-004 120mg&placebo | Placebo comparator | SY-004(globalagliatin hydrochloride) 120mg or placebo by mouth, single dose Receives: Drug: globalagliatin hydrochloride; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single dose of SY-004
number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis)
Measured: 14 day post-dose
Secondary outcomes (7)
AUC of SY-004 following oral administration of single ascending dose
to measure the study drug concentration in blood and urine samples to be collected after drug administration.
Measured: up to 168 hours post-dose
Cmax of SY-004 following oral administration of single ascending dose.
to measure the study drug concentration in blood and urine samples to be collected after drug administration.
Measured: up to 168 hours post-dose
T1/2 of SY-004 following oral administration of single ascending dose
to measure the study drug concentration in blood and urine samples to be collected after drug administration.
Measured: up to 168 hours post-dose
CL/F of SY-004 following oral administration of single ascending dose
to measure the study drug concentration in blood and urine samples to be collected after drug administration.
Measured: up to 168 hours post-dose
glucose levels following single dose of SY-004
FPG AUC
Measured: up to 48 hours post-dose
insulin secretion following single dose of SY-004
insulin changes
Measured: up to 11 hours post-dose
C-peptide secretion following single dose of SY-004
C-peptide change
Measured: up to 11 hour post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start5 Apr 2017
- Primary completion25 Sep 2017
- Study completion9 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperglycaemia (Diabetic)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yabao Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Yang, Study director, Yabao pharmaceutical Group Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171623
- Sponsor's protocol ID
- YB002003
- Status last verified
- Jan 2018
- First submitted
- 5 May 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao Y, Xie L, Zhang H, Zhou S, Liu Y, Chen J, Wang L, Wang L, Zhuo L, Wang Y, Ou N, Shao F. Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of SY-004, a Glucokinase Activator, in Healthy Chinese Adults: A Randomized, Phase Ia, Single-Ascending Dose Study. Clin Ther. 2022 Feb;44(2):269-281. doi: 10.1016/j.clinthera.2021.12.009. Epub 2022 Jan 29.
PubMed 35093240
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised,Double-blind,Placebo-controlled Study to Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride (SY-004) in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT03171623
- Acronym / sponsor ID
- YB002003
- Conditions
- Hyperglycaemia (Diabetic), Healthy Volunteers
- Keywords
- T2DM, Diabetes, GKA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yabao Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004).
Detailed description
Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is expressed in pancreatic islet beta cells where it acts as a "glucose sensor" for insulin release. Activation of glucokinase increases the glucose sensitivity of insulin secretion, effectively lowering the glucose threshold for insulin secretion. Because of its potential to enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for use as a treatment for hyperglycaemia,glubalagliatin( the active ingredient in SY-004 capsule) is being investigated for use as a treatment for T2DM patients. This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of SY-004 administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of SY-004.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SY-004 2mg | Experimental | Drug: globalagliatin hydrochlorideSY-004 (globalagliatin hydrochloride) 2mg by mouth, single dose |
| SY-004 20mg&placebo | Placebo comparator | Drug: globalagliatin hydrochloride, Drug: placeboSY-004 (globalagliatin hydrochloride) 20mg or placebo by mouth, single dose |
| SY-004 40mg&placebo | Placebo comparator | Drug: globalagliatin hydrochloride, Drug: placeboSY-004 (globalagliatin hydrochloride) 40mg or placebo by mouth, single dose |
| SY-004 80mg&placebo | Placebo comparator | Drug: globalagliatin hydrochloride, Drug: placeboSY-004 (globalagliatin hydrochloride) 80mg or placebo by mouth, single dose |
| SY-004 120mg&placebo | Placebo comparator | Drug: globalagliatin hydrochloride, Drug: placeboSY-004(globalagliatin hydrochloride) 120mg or placebo by mouth, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females between the ages of 18 and 65 years, inclusive, healthy subjects
- A screening body mass index (BMI) of 18 to 26 kg/m2 inclusive, body weight above 50kg
- FPG≥3.9mmol/L and <6.1 mmol/L
- Have medical history, physical examination, laboratory tests and other relative test results within the normal range or with abnormalities deemed clinically insignificant by the investigator.
- Have given written informed consent.
Key exclusion criteria (16 listed)
- There is a serious history of systemic disease, or a family history (including cardiovascular system, digestive system, urinary system, etc.)
- Have taken a special diet or exercise before 48 hours of drug administration or other factors are capable of significantly altering the absorption, or metabolism or elimination of drugs.
- A significant abnormality in ALT,AST or other lab test results
- Frontal chest X light result is clinical significantly abnormal.
- Have known intolerance of or allergies to glucokinase activators, or related compounds.
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 |
|---|---|---|
| globalagliatin hydrochlorideAlso: SY-004 capsuleorally administration, single dose | Drug | SY-004 120mg&placebo, SY-004 20mg&placebo, SY-004 2mg, SY-004 40mg&placebo, SY-004 80mg&placebo |
| placeboorally administration, single dose | Drug | SY-004 120mg&placebo, SY-004 20mg&placebo, SY-004 40mg&placebo, SY-004 80mg&placebo |
Primary outcome
Safety and tolerability of single dose of SY-004
Time frame: 14 day post-dose
number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis)
7 secondary outcomes
AUC of SY-004 following oral administration of single ascending dose
Time frame: up to 168 hours post-dose
Cmax of SY-004 following oral administration of single ascending dose.
Time frame: up to 168 hours post-dose
T1/2 of SY-004 following oral administration of single ascending dose
Time frame: up to 168 hours post-dose
CL/F of SY-004 following oral administration of single ascending dose
Time frame: up to 168 hours post-dose
glucose levels following single dose of SY-004
Time frame: up to 48 hours post-dose
insulin secretion following single dose of SY-004
Time frame: up to 11 hours post-dose
C-peptide secretion following single dose of SY-004
Time frame: up to 11 hour post-dose
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 31 Jan 2018.
- Derived from this study: PubMed 35093240Zhao Y, Xie L, Zhang H, Zhou S, Liu Y, Chen J, Wang L, Wang L, Zhuo L, Wang Y, Ou N, Shao F. Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of SY-004, a Glucokinase Activator, in Healthy Chinese Adults: A Randomized, Phase Ia, Single-Ascending Dose Study. Clin Ther. 2022 Feb;44(2):269-281. doi: 10.1016/j.clinthera.2021.12.009. Epub 2022 Jan 29.
- Individual participant dataSharing planned: No
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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.
Lei Yang study director
Yabao pharmaceutical Group Co.
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 globalagliatin hydrochloride in people with Hyperglycaemia (Diabetic) and Healthy Volunteers, run by Yabao Pharmaceutical Group 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 6 inclusion and 16 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 31 Jan 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?
Safety and tolerability of single dose of SY-004 (time frame: 14 day post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171623, which also lists 1 linked publication.
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 31 Jan 2018.