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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
orally administration, single dose
orally administration, single dose
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
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)
Time frame: 14 day post-dose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 168 hours post-dose
glucose levels following single dose of SY-004
FPG AUC
Time frame: up to 48 hours post-dose
insulin secretion following single dose of SY-004
insulin changes
Time frame: up to 11 hours post-dose
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C-peptide secretion following single dose of SY-004
C-peptide change
Time frame: up to 11 hour post-dose