The Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171623
• Other study ID #: YB002003
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2017
• Last updated: January 29, 2018
• Start date: April 5, 2017
• Est. completion date: January 9, 2018

Study information

• Verified date: January 2018
• Source: Yabao Pharmaceutical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 9, 2018
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 )

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Hyperglycaemia (Diabetic)
• Hyperglycemia

Intervention

Drug:
• globalagliatin hydrochloride
orally administration, single dose
• placebo
orally administration, single dose

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yabao Pharmaceutical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	14 day post-dose
Secondary	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.	up to 168 hours post-dose
Secondary	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.	up to 168 hours post-dose
Secondary	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.	up to 168 hours post-dose
Secondary	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.	up to 168 hours post-dose
Secondary	glucose levels following single dose of SY-004	FPG AUC	up to 48 hours post-dose
Secondary	insulin secretion following single dose of SY-004	insulin changes	up to 11 hours post-dose
Secondary	C-peptide secretion following single dose of SY-004	C-peptide change	up to 11 hour post-dose