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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BAY1841788 (ODM-201) + Rosuvastatin All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin (5 mg), once alone and once in combination with BAY1841788 (ODM-201). |
Drug: Rosuvastatin
5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.
Drug: BAY1841788 (ODM-201)
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
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Age: 45 to 65 years at the screening visit.
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Race: White.
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Body mass index (BMI): ≥18.0 and ≤29.9 kg/m*2.
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Adequate venous access (frequent blood sampling).
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Ability to understand and follow study-related instructions.
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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.
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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:
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Medical and surgical history
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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).
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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.
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Febrile illness within 1 week before the first study drug administration.
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A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT interval in electrocardiogram Syndrome) or other arrhythmias.
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History of myopathia after treatment with statins.
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History of rhabdomyolysis or myopathia.
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Medical history of any type of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts.
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History of thyroid disorders, especially hypothyreosis.
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History of respiratory disorder (excluding history of bronchitis or pneumonia).
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History of myasthenia.
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History of muscle pain or muscle ache, muscle soreness of unknown origin or on frequent occasions although an origin might have been found.
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History of any clinically significant hypoglycemia or hyperglycemia.
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Relevant hepatic disorders like a history of viral hepatitis, cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRS Clinical Research Services Berlin GmbH | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17723
- 2015-003244-38