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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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Rosuvastatin
Drug: Rosuvastatin + BI 1323495
Drug: Dabigatran etexilate + BI 1323495
Drug: Dabigatran etexilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04257032
2019-004245-33 (EudraCT Number)
1405-0015

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 4 patient groups

Reference 1 (R1)
Experimental group
Treatment:
Drug: Rosuvastatin
Test 1 (T1)
Experimental group
Treatment:
Drug: Rosuvastatin + BI 1323495
Reference 2 (R2)
Experimental group
Treatment:
Drug: Dabigatran etexilate
Test 2 (T2)
Experimental group
Treatment:
Drug: Dabigatran etexilate + BI 1323495

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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