Clinical trial NCT04198948: Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Official title: Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Sarajevo
Sponsor class: OTHER
Collaborators: name: General Hospital Prim. Dr. Abdulah Nakas
name: University of Dundee
name: Wellcome Trust
First posted: 2019-12-13
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents particularly widely used in developing countries. Gliclazide, a recommended SU drug, is metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.


Eligibility criteria: Inclusion Criteria:

* Men
* Age 18-30 years
* Non-smokers
* CYP2C19 extensive/ultrarapid metabolisers

Exclusion Criteria:

* medical history of hepatic, renal, gastrointestinal and hematologic disease or any acute or chronic disease, or drug allergy to sulfonylureas or PPIs or history of drug abuse
* abnormalities in physical examination, ECG and routine clinical laboratory tests (including fasting blood glucose concentration)
* medication use during the 14 days prior and during the study period
* grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines use during 72 h prior and during the study period

Primary outcomes:
measure: Gliclazide AUC
timeFrame: 24 hours
Secondary outcomes:
measure: Glucose
timeFrame: 12 hours
measure: Insulin
timeFrame: 12 hours
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital Prim. Dr. Abdulah Nakas
Study officials:
affiliation: University of Sarajevo
name: Tanja Dujic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sarajevo
name: Aida Kulo Cesic, PhD
role: PRINCIPAL_INVESTIGATOR
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