Back to resultsAn Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gemigliptin 25mg
Gemigliptin 50mg
Gemigliptin 100mg
Gemiglptin 50mg multiple dose
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female subjects (aged 19~45 years at the time of screening)
- Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
- Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
- Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.
Exclusion Criteria:
- Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
- Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
- Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
Sites / Locations
- Shanghai Xuhui Central hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
25mg SAD
50mg SAD
100mg SAD
50mg Multiple dosing
Arm Description
Outcomes
Primary Outcome Measures
AUClast of Gemigliptin
Cmax of Gemigliptin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03864432
Brief Title
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Official Title
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
October 3, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25mg SAD
Arm Type
Experimental
Arm Title
50mg SAD
Arm Type
Experimental
Arm Title
100mg SAD
Arm Type
Experimental
Arm Title
50mg Multiple dosing
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemigliptin 25mg
Intervention Description
Gemigliptin 50mg 1/2T
Intervention Type
Drug
Intervention Name(s)
Gemigliptin 50mg
Intervention Description
Gemigliptin 50mg 1T
Intervention Type
Drug
Intervention Name(s)
Gemigliptin 100mg
Intervention Description
Gemigliptin 50mg 2T
Intervention Type
Drug
Intervention Name(s)
Gemiglptin 50mg multiple dose
Intervention Description
Gemigliptin 50mg 1T * 10days
Primary Outcome Measure Information:
Title
AUClast of Gemigliptin
Time Frame
0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Title
Cmax of Gemigliptin
Time Frame
0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female subjects (aged 19~45 years at the time of screening)
Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.
Exclusion Criteria:
Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan-Mei Liu
Organizational Affiliation
Shanghai Xuhui District Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui Central hospital
City
Shanghai
ZIP/Postal Code
200002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
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