NCT03789890

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	BAY1902607	BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
DRUG	Itraconazole	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.

Timeline

• Start date: 2019-01-08
• Primary completion: 2019-03-04
• Completion: 2019-05-23
• First posted: 2018-12-31
• Last updated: 2019-05-29

Locations

1 site across 1 country: Germany