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

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Drug Interaction; Pharmacokinetics

Treatments: Drug: Rosuvastatin; Drug: BAY1841788 (ODM-201)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02671097

2015-003244-38 (EudraCT Number)

17723

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

BAY1841788 (ODM-201) + Rosuvastatin

Experimental group

Description:

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).

Treatment:

Drug: Rosuvastatin

Drug: BAY1841788 (ODM-201)