Drug Interactions
Conditions
Keywords
Drug-drug interaction, Itraconazole (ITZ), Cytochrom P450 3A4 (CYP3A4) metabolism, P2X3-inhibitor
Brief summary
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.
Interventions
DRUGBAY1902607
BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
DRUGItraconazole
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.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, male adults * Body mass index ≥ 18 and ≤ 30.0 kg/m² * Body weight ≥ 50 kg
Exclusion criteria
* Known or suspected allergy or hypersensitivity to BAY1902607, itraconazole or any of their excipients * Contraindications to itraconazole (symptoms or history of ventricular dysfunction, heart failure, liver disease). * Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first drug administration or during the trial until follow-up (occasional use of ibuprofen is permissible). Particularly, this includes drugs that might affect the pharmacokinetics (PK) of BAY1902607, e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, CYP3A4 inhibitors or inducers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of BAY1902607 | -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 | -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 | -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 | -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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Up to 5 weeks | — |
| Intensity of treatment-emergent adverse events | 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). |
Countries
Germany
Outcome results
None listed