Clinical trial NCT03048110: Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biological Availability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2017-02-09
Enrollment: 15
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: 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
timeFrame: Pre dose to 72 hours post dose of darolutamide
measure: Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: 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
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: 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
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: 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
timeFrame: Pre dose up to 72 hours post dose of darolutamide
measure: Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
timeFrame: Pre dose up to 72 hours post dose of darolutamide
Secondary outcomes:
measure: Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to 30 days after last dose of study medication
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: