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Trial record 5 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03789890
Recruitment Status : Active, not recruiting
First Posted : December 31, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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 : January 8, 2019
Actual Primary Completion Date : March 4, 2019
Estimated Study Completion Date : May 9, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cmax of BAY1902607 [ Time 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 ]
    Maximum concentration of BAY1902607 in blood

  2. Cmax of BAY1902607 with itraconazole [ Time 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 ]
    Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole

  3. AUC of BAY1902607 [ Time 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 ]
    Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose

  4. AUC of BAY1902607 with itraconazole [ Time 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 ]
    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 [ Time Frame: Up to 5 weeks ]
  2. Intensity of treatment-emergent adverse events [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789890


Locations
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Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03789890     History of Changes
Other Study ID Numbers: 19431
2018-003212-50 ( EudraCT Number )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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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:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors