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)
1 other identifier
interventional
48
1 country
1
Brief Summary
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Jul 2019
Typical duration for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedStudy Start
First participant enrolled
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedMarch 3, 2020
March 1, 2020
3 months
March 4, 2019
March 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast of Gemigliptin
0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Cmax of Gemigliptin
0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Study Arms (4)
25mg SAD
EXPERIMENTAL50mg SAD
EXPERIMENTAL100mg SAD
EXPERIMENTAL50mg Multiple dosing
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (1)
Shanghai Xuhui Central hospital
Shanghai, 200002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan-Mei Liu
Shanghai Xuhui District Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 6, 2019
Study Start
July 2, 2019
Primary Completion
October 3, 2019
Study Completion
February 28, 2020
Last Updated
March 3, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share