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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03789890
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Interactions	Drug: BAY1902607; Drug: Itraconazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 8, 2019
• Actual Primary Completion Date: Mar 4, 2019
• Actual Study Completion Date: May 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Cmax of BAY1902607 [-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]

   Maximum concentration of BAY1902607 in blood

2. Cmax of BAY1902607 with 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]

   Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole

3. AUC of BAY1902607 [-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]

   Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose

4. AUC of BAY1902607 with 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]

   Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole

Other Outcome Measures

1. Number of participants with treatment-emergent adverse events [Up to 5 weeks]

2. Intensity of treatment-emergent adverse events [Up to 5 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Berlin GmbH	Berlin		Germany	13353

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03789890
• Other Study ID Numbers: 19431; 2018-003212-50
• First Posted: Dec 31, 2018
• Last Update Posted: May 29, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Drug-drug interaction; Itraconazole (ITZ); Cytochrom P450 3A4 (CYP3A4) metabolism; P2X3-inhibitor
• Additional relevant MeSH terms: Itraconazole

Study Results

No Results Posted as of May 29, 2019