Drug-drug interaction (DDI) study to assess ODM-201 as a victim of CYP3A4 inhibition or induction
Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)
- Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring. - Gender: Male. - Age: 45 to 65 years (inclusive) at the screening visit. - Race: White. - Body mass index (BMI): ≥18.0 and ≤30 kg/m^2. - Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with ODM-201. In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception. - Results of alcohol tests are negative at screening and on Study Day -1.
- Medical and surgical history - Existing relevant diseases of vital organs (e.g. liver diseases, heart 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 drugs will not be normal. - Febrile illness within 1 week before the first study drug administration. - A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias. - Known severe allergies, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated, asymptomatic seasonal allergies like non-severe hay fever during the time of study conduct). - Known history of hypersensitivity (or known allergic reaction) to itraconazole, rifampicin or ODM-201. - Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease. - Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation. - Subjects with porphyria. - Subjects with diagnosed malignancy within the past 5 years except for cured skin basal carcinoma.
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
E-mail: [email protected]
Phone: +49 30 300139003
A Phase I, non-randomized, open-label, fixed-sequence study to investigate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM 201) in healthy male volunteers
Single Group Assignment