Trial Condition(s):
Drug interactions
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
Bayer Identifier:
19431
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Healthy, male adults
- Body mass index ≥ 18 and ≤ 30.0 kg/m²
- Body weight ≥ 50 kgExclusion 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.Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Cmax of BAY1902607Maximum concentration of BAY1902607 in bloodTimeframe: -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
- Cmax of BAY1902607 with itraconazoleMaximum concentration of BAY1902607 in blood with concomitant administration of itraconazoleTimeframe: -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
- AUC of BAY1902607Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single doseTimeframe: -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
- AUC of BAY1902607 with itraconazoleArea under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazoleTimeframe: -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
Additional Information
Not Available
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