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

NCT ID: NCT03789890

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2019-05-23

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy men

Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase.

Group Type: EXPERIMENTAL

BAY1902607

Intervention Type: DRUG

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

Itraconazole

Intervention Type: DRUG

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.

Interventions

BAY1902607

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2018-003212-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19431

Identifier Type: -

Identifier Source: org_study_id