NCT02507167|CompletedPhase 1DMC
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Sponsor study identifier
interventional
19
1 country
1
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
December 2014
Actual (reported)The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2 on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose standardized liquid mixed meal.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2013
Actual (reported)December 2014
Actual (reported)July 22, 2015
Actual (reported)July 23, 2015
Actual (reported)CCK-8
Cholecystokinin amino acid 8 concentration in blood plasma
3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal
GLP-1
3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal
GIP
3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal
glucagon
3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal
glucose
3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal
potassium
3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal
area under the curve AUC from zero to the last sampling time above the limit of quantitation (AUC0-t) of rifampin and DAc-RIF (25-O-desacetyl-rifampin)
3 h 15 min up to 2 h 15 min, 1.5, 1 h before and 5 min, 1, 2, 3, 4, 6, 8, 10 and 14 h after mixed meal
area under the curve AUC from zero to 4 h (AUC0-4h) of rifampin and DAc-RIF (25-O-desacetyl-rifampin)
3 h 15 min up to 2 h 15 min, 1.5, 1 h before and 5 min, 1, 2 h after mixed meal
maximal concentration (Cmax) of rifampin and DAc-RIF (25-O-desacetyl-rifampin)
3 h 15 min up to 2 h 15 min, 1.5, 1 h before and 5 min, 1, 2, 3, 4, 6, 8, 10 and 14 h after mixed meal
250 ml Fortimel compact (chocolate)
oral rifampin administration (600 mg EREMFAT®)
Department of Clinical Pharmacology
Greifswald, 17489, Germany
Werner Siegmund, Prof
Department of Clinical Pharmacology
19 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2015
First Posted
July 23, 2015
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2013
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
July 23, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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