Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

• ClinicalTrials.gov Identifier: NCT03565458
• Recruitment Status: Unknown
• First Posted: June 21, 2018
• Last Update Posted: June 21, 2018
• Sponsor: LG Chem
• Information provided by (Responsible Party): LG Chem

Study Description

Brief Summary:

gemigliptin,SGLT-2i DDI study

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Gemigliptin; Drug: Dapagliflozin; Drug: Empagliflozin	Phase 1

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 5, 2018
• Estimated Primary Completion Date: August 20, 2018
• Estimated Study Completion Date: December 22, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: gemigliptin; gemigliptin single dose	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Name: zemiglo
Experimental: dapagliflozin; dapagliflozin single dose	Drug: Dapagliflozin; forxiga, dapagliflozin 10mg; Other Name: forxiga
Experimental: gemigliptin and dapagliflozin; co-administration of gemigliptin and dapagliflozin	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Name: zemiglo; Drug: Dapagliflozin; forxiga, dapagliflozin 10mg; Other Name: forxiga
Experimental: empagliflozin; empagliflozin single dose	Drug: Empagliflozin; jardiance 25mg, empagliflozin; Other Name: jardiance
Experimental: gemigliptin and empagliflozin; co-administration of gemigliptin and empagliflozin	Drug: Gemigliptin; zemiglo 50mg,LG Chem; Other Name: zemiglo; Drug: Empagliflozin; jardiance 25mg, empagliflozin; Other Name: jardiance

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 55 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

LG chem

Seoul, Gangseo-Gu, Korea, Republic of, 07795

Sponsors and Collaborators

LG Chem

Investigators

• Principal Investigator: jungryul kim, doctor; samsung seoul medical center

More Information

• Responsible Party: LG Chem
• ClinicalTrials.gov Identifier: NCT03565458
• Other Study ID Numbers: LG-DPCL018
• First Posted: June 21, 2018
• Last Update Posted: June 21, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Dapagliflozin; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Physiological Effects of Drugs