Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY1902607 Given One Time by Mouth Acts in the Human Body of Healthy Male Participants
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|ClinicalTrials.gov Identifier: NCT03789890|
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : May 29, 2019
BAY1902607 is a new type of drug under clinical development for different conditions including the treatment of endometriosis, i.e. a condition where the tissue that usually grows inside the womb grows outside of the womb.
Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed by the human body, reaches the blood stream and is excreted again. In addition they want to find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at the same time.
|Condition or disease||Intervention/treatment||Phase|
|Drug Interactions||Drug: BAY1902607 Drug: Itraconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Group Study to Evaluate the Effect of Repeated Oral Administration of Itraconazole (ITZ) on the Single Oral Dose Pharmacokinetics of BAY1902607 in Healthy Male Participants|
|Actual Study Start Date :||January 8, 2019|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||May 23, 2019|
Experimental: Healthy men
Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.
BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2.
- Cmax of BAY1902607 [ Time Frame: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug ]Maximum concentration of BAY1902607 in blood
- Cmax of BAY1902607 with itraconazole [ Time Frame: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607 ]Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole
- AUC of BAY1902607 [ Time Frame: -0.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 96 hours after drug ]Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose
- AUC of BAY1902607 with itraconazole [ Time Frame: -1.5 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours after BAY1902607 ]Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole
- Number of participants with treatment-emergent adverse events [ Time Frame: Up to 5 weeks ]
- Intensity of treatment-emergent adverse events [ Time Frame: Up to 5 weeks ]Adverse events will be assigned to one of three categories: mild (easily tolerated and no interference with everyday activities), moderate (sufficient discomfort and interferes with everyday activities) & severe (prevents normal everyday activities).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789890
|CRS Clinical Research Services Berlin GmbH|
|Berlin, Germany, 13353|