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

• Status: Completed
• Trial end date: 2017-07-19
• Target enrollment: 0
• Participant gender: Male

Summary

Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Hydroxyitraconazole; Itraconazole; Rifampin

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.