Trial Condition(s):

Healthy Volunteers, Pharmacokinetics, Drug Interaction

Drug-drug interaction study using rosuvastatin as a breast cancer resistant protein (efflux transporter), organic anion-transporting polypeptide (OATP)1B1, and OATP1B3 (uptake transporters) probe substrate

Bayer Identifier:

17723

ClinicalTrials.gov Identifier:

NCT02671097

EudraCT Number:

2015-003244-38

Study Completed

Trial Purpose

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics.
PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

Inclusion Criteria
- Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
- Age: 45 to 65 years at the screening visit.
- Race: White.
- Body mass index (BMI): ≥18.0 and ≤29.9 kg/m*2.
- Adequate venous access (frequent blood sampling).
- Ability to understand and follow study-related instructions.
- Females have to be in postmenopausal state, revealed by: Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drugadministration) and follicle stimulating hormone (FSH) >40 IU/L at screening examination.
-  Male subjects must agree to use condoms as an effective contraception barrier method during the whole study (starting after informed consent) and for 3 months after the end of treatment with BAY1841788 (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.
Exclusion Criteria
- Medical and surgical history
-- Subjects with clinically relevant findings in medical history e.g. history or currently existing relevant diseases of vital organs, 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 interval in electrocardiogram Syndrome) or other arrhythmias.
- History of myopathia after treatment with statins.
-- History of rhabdomyolysis or myopathia.
-- Medical history of any type of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts.
-- History of thyroid disorders, especially hypothyreosis.
-- History of respiratory disorder (excluding history of bronchitis or pneumonia).
-- History of myasthenia.
-- History of muscle pain or muscle ache, muscle soreness of unknown origin or on frequent occasions although an origin might have been found.
-- History of any clinically significant hypoglycemia or hyperglycemia.
-- Relevant hepatic disorders like a history of viral hepatitis, 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.

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 

Trial Design