Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction

Launched by BAYER · Feb 8, 2017

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.