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:

NCT03789890

EudraCT Number:

2018-003212-50

Study Completed

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 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.

Trial Summary

Enrollment Goal
14
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1902607
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 

Trial Design