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A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257032
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin Drug: Rosuvastatin + BI 1323495 Drug: Dabigatran etexilate Drug: Dabigatran etexilate + BI 1323495 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part)
Actual Study Start Date : February 13, 2020
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : September 23, 2020


Arm Intervention/treatment
Experimental: Reference 1 (R1) Drug: Rosuvastatin
Tablet

Experimental: Test 1 (T1) Drug: Rosuvastatin + BI 1323495
Tablets

Experimental: Reference 2 (R2) Drug: Dabigatran etexilate
Capsule

Experimental: Test 2 (T2) Drug: Dabigatran etexilate + BI 1323495
Capsule and tablets




Primary Outcome Measures :
  1. Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 5 days ]
  2. Maximum measured concentration of Rosuvastatin in plasma (Cmax) [ Time Frame: up to 5 days ]
  3. Area under the concentration-time curve of Dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 4 days ]
  4. Maximum measured concentration of Dabigatran in plasma (Cmax) [ Time Frame: up to 4 days ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: up to 5 days ]
  2. Area under the concentration-time curve of Dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: up to 4 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  2. Age of 18 to 55 years (inclusive)
  3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
  4. Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
  5. Subjects genotyped as Uridine 5'-diphospho-Glucuronosyltransferase-2B17 (UGT2B17) extensive metabolisers, i.e. carrying at least one functional allele of UGT2B17 gene (*1/*1 or *1/*2)

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (including positive or missing faecal occult blood test in Part 2)
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  8. History of relevant orthostatic hypotension, fainting spells, or blackouts
  9. Chronic or relevant acute infections
  10. History of relevant allergy or hypersensitivity (including allergy to the trial medications or their excipients)
  11. Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial or compromise the subject's safety by participation in the trial (e. g. use of any drug that could reasonably inhibit platelet aggregation or coagulation, concomitant treatment with systemic cyclosporine, ketoconazole, itraconazole and dronedarone, use of fibrates or drugs that cause QT/QTc interval prolongation (QTc: QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB))
  12. Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  13. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  14. Inability to refrain from smoking on specified trial days
  15. Alcohol abuse (consumption of more than 24 g per day)
  16. Drug abuse or positive drug screening
  17. Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
  18. Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  19. Inability to comply with the dietary regimen of the trial site
  20. A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
  21. A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
  22. Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  23. Male subjects with women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
  24. Active clinically relevant bleeding or subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of blood coagulation disorders, current or recent gastrointestinal ulceration, presence of malignant neoplasms, recent brain or spinal injury, recent brain/spinal/ophthalmic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities
  25. For Part 1 only: known myopathy, personal or family history of hereditary muscular disorders, or history of muscular toxicity with statins or fibrate; Asian ancestry; hypothyroidism
  26. Subjects with any other condition that would preclude administration of rosuvastatin or dabigatran (i.e. contraindicated as per SmPC), such as active liver disease including elevations of serum transaminases exceeding 2 times the upper limit of normal, moderate or severe renal impairment (creatinine clearance < 60 ml/min based on estimated glomerular filtration rate (GFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula), prosthetic heart valves requiring anticoagulant treatment
  27. During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection

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): NCT04257032


Locations
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Germany
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397
Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04257032    
Other Study ID Numbers: 1405-0015
2019-004245-33 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants