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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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ClinicalTrials.gov Identifier: NCT02671097
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Healthy Volunteers Pharmacokinetics Drug Interaction Drug: Rosuvastatin Drug: BAY1841788 (ODM-201) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Number of subjects with study drug-related treatment-emergent Adverse Events [ Time Frame: Up to 30 days ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671097


Locations
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Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02671097    
Other Study ID Numbers: 17723
2015-003244-38 ( EudraCT Number )
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors