Phase
Condition
Healthy Volunteers
Treatment
BAY2927088
Itraconazole
Carbamazepine
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Capable of giving signed informed consent as described in protocol, which includescompliance with the requirements and restrictions listed in the informed consentform (ICF), and in this protocol.
Participant must be 18 to 55 years of age inclusive, at the time of signing theinformed consent.
Participants who are overtly healthy as determined by the investigator or medicallyqualified designee based on medical evaluation including medical history, laboratorytests, physical, and cardiac examination.
Participant is a nonsmoker who has not used tobacco- or nicotine- containingproducts (eg., nicotine patch) for at least 6 months before administration of thefirst 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 orbreastfeeding, and must be documented as a woman of nonchildbearing potential. Anegative pregnancy test is required.
Male study participants of reproductive potential must agree to use adequatecontraception when sexually active. From signing of the ICF until at least 3 monthsafter the last dose of study intervention, and refrain from sperm donation duringstudy intervention and for 6 months after the last dose of study intervention.
Participant must be willing to comply with dietary and fluid requirements during thestudy period (including abstaining from alcohol use).
Exclusion
Exclusion Criteria:
Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases,gastrointestinal diseases, interstitial lung disease, renal diseases), centralnervous system (for example seizures) or other organs (e.g., diabetes mellitus).
Incompletely cured pre-existing diseases for which it can be assumed that theabsorption, distribution, metabolism, elimination, and effects of the studyintervention 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 interventionadministration as judged by the investigator.
A medical history of risk factors for Torsades de pointes (e.g., family history oflong QT syndrome) or other clinically significant arrhythmias as judged by theinvestigator.
Known severe allergies, allergies requiring therapy with corticosteroids,significant non-allergic drug reactions, or (multiple) drug allergies (excludingseasonal allergies such as non-severe hay fever that are asymptomatic and untreatedduring the time of study conduct).
Known history of hypersensitivity (or known allergic reaction) to BAY2927088 relatedcompounds, 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 mooddisorders 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.
Study Design
Connect with a study center
PAREXEL International, Baltimore
Baltimore, Maryland 21225
United StatesActive - Recruiting
Parexel Baltimore - Early Phase Clinical Unit
Baltimore, Maryland 21225
United StatesSite Not Available
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