Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Drug Interactions
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 grow...
Eligibility Criteria
Inclusion
- Healthy, male adults
- Body mass index ≥ 18 and ≤ 30.0 kg/m²
- Body weight ≥ 50 kg
Exclusion
- 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.
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03789890
Start Date
January 8 2019
End Date
May 23 2019
Last Update
May 29 2019
Active Locations (1)
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1
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353