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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02671097
• Date of registration: 29/01/2016
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: 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
• Scientific title: A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers
• Date of first enrolment: February 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02671097
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: 45 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Drug Interaction

Healthy Volunteers

Pharmacokinetics

Intervention(s)

Drug: BAY1841788 (ODM-201)

Drug: Rosuvastatin

Primary Outcome(s)

Maximum drug concentration (Cmax) in plasma of Rosuvastatin [Time Frame: 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]

Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24)) [Time Frame: 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(s)

Number of subjects with study drug-related treatment-emergent Adverse Events [Time Frame: Up to 30 days]

Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration [Time Frame: 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 [Time Frame: 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]

Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration [Time Frame: 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]

Secondary ID(s)

2015-003244-38

17723

Source(s) of Monetary Support

Please refer to primary and secondary sponsors