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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
45–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
