Drug-drug Interaction (DDI) Study to Assess ODM-201 as a... | NCT03048110

NCT03048110

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2016-004469-20	EudraCT Number

Status Module

Name	Class
Orion Corporation, Orion Pharma	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ODM-201	Experimental	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	Drug: BAY1841788 (ODM-201) Drug: Itraconazole Drug: Rifampicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY1841788 (ODM-201)	Drug	In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide	Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.	Pre dose to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide	Maximum observed concentration after single dose administration in plasma were measured.	Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide	Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.	Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide	Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.	Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide	Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.	Pre dose up to 72 hours post dose of darolutamide

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). AEs that occurred on study drug administration were termed as study drug related adverse events.

Eligibility Module

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.

ID	Term
C000607739	darolutamide
D017964	Itraconazole
D012293	Rifampin

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds