check_circleStudy Completed

Drug Interactions

Bayer Identifier:

19431

ClinicalTrials.gov Identifier:

NCT03789890

EudraCT Number:

2018-003212-50

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - Healthy, male adults
    - Body mass index ≥ 18 and ≤ 30.0 kg/m²
    - Body weight ≥ 50 kg

  • - 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 summary

Enrollment Goal
14
Trial Dates
January 2019 - May 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1902607
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Cmax of BAY1902607
    Maximum concentration of BAY1902607 in blood
    date_rangeTime Frame:
    -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
    date_rangeTime Frame:
    -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
    date_rangeTime Frame:
    -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
    date_rangeTime Frame:
    -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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1