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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

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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