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

NCT03789890 | Completed Phase 1

• 2 other identifiers: 194312018-003212-50
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Drug-drug interaction; Itraconazole (ITZ); Cytochrom P450 3A4 (CYP3A4) metabolism; P2X3-inhibitor

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Number of participants with treatment-emergent adverse events

  Up to 5 weeks

• Intensity of treatment-emergent adverse events

  Up to 5 weeks

Study Arms (1)

Healthy men

EXPERIMENTAL

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; Drug: Itraconazole

Interventions

BAY1902607 DRUG

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

Healthy men

Itraconazole 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.

Healthy men

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, male adults
• Body mass index ≥ 18 and ≤ 30.0 kg/m²
• Body weight ≥ 50 kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: January 8, 2019
• Primary Completion: March 4, 2019
• Study Completion: May 23, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

DE (1)