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

Bayer

Status and phase: Completed; Phase 1

Conditions: Biological Availability

Treatments: Drug: Rifampicin; Drug: BAY1841788 (ODM-201); Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03048110

17726

2016-004469-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ODM-201

Experimental group

Description:

All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period

Treatment:

Drug: Itraconazole

Drug: BAY1841788 (ODM-201)

Drug: Rifampicin