Clareo Health | A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants
A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Capable of giving signed informed consent as described in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), and in this protocol.
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, and cardiac examination.
Participant is a nonsmoker who has not used tobacco- or nicotine- containing products (eg., nicotine patch) for at least 6 months before administration of the first study intervention.
Body mass index (BMI) within the range 18.0 to 30 kg/m2 (inclusive) at screening, with bodyweight above/equal to 50 kg.
Female, of non childbearing potential only. Females must not be pregnant or breastfeeding, and must be documented as a woman of nonchildbearing potential. A negative pregnancy test is required.
Male study participants of reproductive potential must agree to use adequate contraception when sexually active. From signing of the ICF until at least 3 months after the last dose of study intervention, and refrain from sperm donation during study intervention and for 6 months after the last dose of study intervention.
Participant must be willing to comply with dietary and fluid requirements during the study period (including abstaining from alcohol use).
You may not be if
Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease, renal diseases), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus).
Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal.
Febrile illness within 4 weeks prior to admission to the clinic.
Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator.
A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator.
Known severe allergies, allergies requiring therapy with corticosteroids, significant non-allergic drug reactions, or (multiple) drug allergies (excluding seasonal allergies such as non-severe hay fever that are asymptomatic and untreated during the time of study conduct).
Known history of hypersensitivity (or known allergic reaction) to BAY2927088 related compounds, or any components of the formulation, itraconazole or carbamazepine (HLA-A 31:01 or HLA-B 15:02 allele for Arm 2 only)
History of known or suspected malignant tumors.
Participants with any type of ongoing psychiatric disorder, especially any mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent.
History of clinically relevant depression, or suicidal ideation or behavior.
