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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671097
• Other study ID #: 17723
• Secondary ID: 2015-003244-38
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2016
• Last updated: September 7, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Drug Interaction
• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• Rosuvastatin
5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.
• 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.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of subjects with study drug-related treatment-emergent Adverse Events		Up to 30 days	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No

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