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

Status and phase: Completed; Phase 1

Conditions: Drug Interactions

Treatments: Drug: Itraconazole; Drug: BAY1902607

Study type: Interventional

Funder types: Industry

Identifiers

NCT03789890

2018-003212-50 (EudraCT Number)

19431

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Healthy men

Experimental group

Description:

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.

Treatment:

Drug: BAY1902607

Drug: Itraconazole