Trial Outcomes & Findings for Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers (NCT NCT04198948)
NCT ID: NCT04198948
Last Updated: 2021-08-18
Results Overview
Area under the concentration-time curve (AUC) up to the last concentration measured
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
24 hours
Results posted on
2021-08-18
Participant Flow
A total of 37 volunteers were recruited in the period between March 4th, 2019 and May 29th, 2019. On May 30th, 2019, volunteers were screened for CYP2C19 genotype status at the General Hospital in Sarajevo, B\&H.
From 23 individuals, CYP2C19 EM/UM metabolisers, 16 were available for further health status assessment. One participant did not meet inclusion criteria and a total of 15 volunteers were randomised.
Participant milestones
| Measure |
Omeprazole, Then Placebo
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.
Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
|
Placebo, Then Omeprazole
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.
Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
|
|---|---|---|
|
Second Period
STARTED
|
7
|
8
|
|
Second Period
COMPLETED
|
7
|
7
|
|
First Period
STARTED
|
7
|
8
|
|
First Period
COMPLETED
|
7
|
8
|
|
First Period
NOT COMPLETED
|
0
|
0
|
|
Wash-out (10 Days)
STARTED
|
7
|
8
|
|
Wash-out (10 Days)
COMPLETED
|
7
|
8
|
|
Wash-out (10 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Period
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Baseline characteristics by cohort
| Measure |
Omeprazole, Then Placebo
n=7 Participants
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.
Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
|
Placebo, Then Omeprazole
n=8 Participants
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.
Omeprazole: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo oral tablet: Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide: Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.9 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
22.3 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Weight
|
82.2 kilograms
STANDARD_DEVIATION 12.5 • n=5 Participants
|
75.7 kilograms
STANDARD_DEVIATION 10.8 • n=7 Participants
|
78.7 kilograms
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: A total of 14 participants who completed both study periods were included in the analysis.
Area under the concentration-time curve (AUC) up to the last concentration measured
Outcome measures
| Measure |
Gliclazide + Omeprazole
n=14 Participants
Participants received 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
Gliclazide + Placebo
n=14 Participants
Participants received placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
|---|---|---|
|
Gliclazide AUC
|
3.73 μgh/mL
Interval 2.81 to 4.93
|
3.29 μgh/mL
Interval 2.65 to 4.09
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: A total of 14 participants who completed both study periods were included in the analysis.
Change in glucose concentration - incremental area under the glucose concentration-time curve from 0 to 12 h
Outcome measures
| Measure |
Gliclazide + Omeprazole
n=14 Participants
Participants received 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
Gliclazide + Placebo
n=14 Participants
Participants received placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
|---|---|---|
|
Glucose
|
4.6 mmol x h/L
Standard Deviation 4.3
|
4.0 mmol x h/L
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: A total of 14 participants who completed both study periods were included in the analysis.
Change in insulin concentration - incremental area under the insulin concentration-time curve from 0 to 12 h
Outcome measures
| Measure |
Gliclazide + Omeprazole
n=14 Participants
Participants received 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
Gliclazide + Placebo
n=14 Participants
Participants received placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5.
|
|---|---|---|
|
Insulin
|
231.6 mIU x h/L
Standard Deviation 93.8
|
265.9 mIU x h/L
Standard Deviation 78.2
|
Adverse Events
Gliclazide + Omeprazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gliclazide + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Professor Tanja Dujic, PhD
University of Sarajevo
Phone: +38733586194
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place