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

Drug Interactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789890
• Other study ID #: 19431
• Secondary ID: 2018-003212-50
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2019
• Est. completion date: May 23, 2019

Study information

• Verified date: May 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 23, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Interactions

Intervention

Drug:
• BAY1902607
BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
• 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.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-emergent adverse events		Up to 5 weeks
Other	Intensity of treatment-emergent adverse events	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).	Up to 5 weeks
Primary	Cmax of BAY1902607	Maximum concentration of BAY1902607 in blood	-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
Primary	Cmax of BAY1902607 with itraconazole	Maximum concentration of BAY1902607 in blood with concomitant administration of 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
Primary	AUC of BAY1902607	Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose	-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
Primary	AUC of BAY1902607 with itraconazole	Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of 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