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

NCT03171623 | Completed Phase 1

• 1 other identifier: YB002003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyperglycaemia (Diabetic); Healthy Volunteers

Keywords

T2DM; Diabetes; GKA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• AUC of SY-004 following oral administration of single ascending dose

  up to 168 hours post-dose

• Cmax of SY-004 following oral administration of single ascending dose.

  up to 168 hours post-dose

• T1/2 of SY-004 following oral administration of single ascending dose

  up to 168 hours post-dose

• CL/F of SY-004 following oral administration of single ascending dose

  up to 168 hours post-dose

• glucose levels following single dose of SY-004

  up to 48 hours post-dose

Study Arms (5)

SY-004 2mg

EXPERIMENTAL

SY-004 (globalagliatin hydrochloride) 2mg by mouth, single dose

Drug: globalagliatin hydrochloride

SY-004 20mg&placebo

PLACEBO COMPARATOR

SY-004 (globalagliatin hydrochloride) 20mg or placebo by mouth, single dose

Drug: globalagliatin hydrochloride; Drug: placebo

SY-004 40mg&placebo

PLACEBO COMPARATOR

SY-004 (globalagliatin hydrochloride) 40mg or placebo by mouth, single dose

Drug: globalagliatin hydrochloride; Drug: placebo

SY-004 80mg&placebo

PLACEBO COMPARATOR

SY-004 (globalagliatin hydrochloride) 80mg or placebo by mouth, single dose

Drug: globalagliatin hydrochloride; Drug: placebo

SY-004 120mg&placebo

PLACEBO COMPARATOR

SY-004(globalagliatin hydrochloride) 120mg or placebo by mouth, single dose

Drug: globalagliatin hydrochloride; Drug: placebo

Interventions

globalagliatin hydrochloride DRUG

orally administration, single dose

Also known as: SY-004 capsule

SY-004 120mg&placebo; SY-004 20mg&placebo; SY-004 2mg; SY-004 40mg&placebo; SY-004 80mg&placebo

placebo DRUG

orally administration, single dose

SY-004 120mg&placebo; SY-004 20mg&placebo; SY-004 40mg&placebo; SY-004 80mg&placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yabao Pharmaceutical Group: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (1)

• 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.

  PMID: 35093240 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lei Yang

  Yabao pharmaceutical Group Co.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 31, 2017
• Study Start: April 5, 2017
• Primary Completion: September 25, 2017
• Study Completion: January 9, 2018
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)