Trial Condition(s):
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
17723
Not Available
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.
- 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.
- 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.
Locations | Status | |
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Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
A Phase 1, open label, fixed-sequence study to evaluate the effect of BAY1841788 (ODM-201) on drug transporters using rosuvastatin as probe substrate and to assess pharmacokinetics and safety of BAY1841788 in female and male volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1