Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers

gemigliptin,SGLT-2i DDI study

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Gemigliptin; Drug: Dapagliflozin; Drug: Empagliflozin

Detailed Description

LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin & dapagliflozin and gemigliptin & empagliflozin.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangseo-Gu
    • Seoul, Gangseo-Gu, Korea, Republic of, 07795
      • LG Chem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male adults at age between 19 to 55 at the time of the screening
2. Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
3. Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
4. subjects who is consented in writing to be sure to comply with the requirements of the clinical trial

Exclusion Criteria:

1. Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
2. Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
3. Subject who had infection disease or serious injury within 21 days before the randomization
4. Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
5. Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
6. Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
7. Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
8. Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
9. subject who drinks the average amount per week exceeding 140 g of alcohol
10. Subject whose daily average smoking amount exceeds 20 pieces per day
11. Average daily grapefruit juice intake exceeding 2 cups
12. Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
13. Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
14. Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
15. Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
16. Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
17. Subject who have clinically significant abnormalities in other clinical tests
18. Subject with clinically significant abnormal ECG findings
19. Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: gemigliptin; gemigliptin single dose	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Names: zemiglo
EXPERIMENTAL: dapagliflozin; dapagliflozin single dose	Drug: Dapagliflozin; forxiga, dapagliflozin 10mg; Other Names: forxiga
EXPERIMENTAL: gemigliptin and dapagliflozin; co-administration of gemigliptin and dapagliflozin	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Names: zemiglo; Drug: Dapagliflozin; forxiga, dapagliflozin 10mg; Other Names: forxiga
EXPERIMENTAL: empagliflozin; empagliflozin single dose	Drug: Empagliflozin; jardiance 25mg, empagliflozin; Other Names: jardiance
EXPERIMENTAL: gemigliptin and empagliflozin; co-administration of gemigliptin and empagliflozin	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Names: zemiglo; Drug: Empagliflozin; jardiance 25mg, empagliflozin; Other Names: jardiance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin	AUCτ	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin	Css,max	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tss,max of gemigliptin, dapagliflozin, empagliflozin	tss,max	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin	Css,min	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite	AUCτ	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax)of gemigliptin metabolite	Css,max	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration(Css,min) of gemigliptin metabolite	Css,min	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio of gemigliptin	metabolic ratio	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: jungryul kim, doctor, samsung seoul medical center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2018
• Primary Completion (ANTICIPATED): August 20, 2018
• Study Completion (ANTICIPATED): December 22, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Empagliflozin
• Other Study ID Numbers: LG-DPCL018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No