Drug Interaction, Healthy Volunteers, Pharmacokinetics
Conditions
Brief 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.
Interventions
DRUGRosuvastatin
5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.
600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24)) | Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration |
| Maximum drug concentration (Cmax) in plasma of Rosuvastatin | Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with study drug-related treatment-emergent Adverse Events | Up to 30 days |
| Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration | Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration, period 2 day 1 |
| Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration | Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h after BAY1841788 administration, period 2 day 7 |
| Maximum drug concentration (Cmax) in plasma of BAY1841788 | Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration |
Countries
Germany
Outcome results
None listed