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

Conditions: Healthy Volunteers; Pharmacokinetics; Drug Interaction

Summary: 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.


Eligibility criteria:
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.