Study Completed

Biological Availability

Bayer Identifier:

17726

ClinicalTrials.gov Identifier:

NCT03048110

EudraCT Number:

2016-004469-20

EU CT Number:

Not Available

Drug-drug interaction (DDI) study to assess ODM-201 as a victim of CYP3A4 inhibition or induction

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

45 - 65 Years

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 summary

Enrollment Goal

Trial Dates

February 2017 - July 2017

Phase

Phase 1

Could I Receive a placebo

Products

Nubeqa (Darolutamide, BAY1841788)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany

Primary Outcome

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.
Time Frame:
Pre dose to 72 hours post dose of darolutamide
Safety Issue:
No
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.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
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.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
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.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
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.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours (AUC[0-72h]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No
Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
Time Frame:
Pre dose up to 72 hours post dose of darolutamide
Safety Issue:
No

Secondary Outcome

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.
Time Frame:
From start of study drug administration up to 30 days after last dose of study medication
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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