*DDI study of BAY 2927088 (mutEGFR inhibitor) and dabigatran etexilate / rosuvastatin in HV

• Research type

  Research Study

• Full title

  A Phase 1, open label, fixed sequence, crossover study to investigate the effect of BAY 2927088 on the pharmacokinetics of dabigatran etexilate or rosuvastatin in healthy participants

• IRAS ID

  1009400

• Contact name

  Sue Prendergast

• Contact email

  sue.prendergast@bayer.com

• Sponsor organisation

  Bayer AG

• Clinicaltrials.gov Identifier

  NCT06329895

• Research summary

  The trial is a single centre, open label trial in up to 15 healthy males and females (of non-childbearing potential) between the ages of 18 to 55 years.

  The medicine to be tested is this trial is a compound called BAY 2927088 being developed for treating non-small cell lung cancer with human epidermal growth factor receptor 2 (HER2) or epidermal growth factor receptor (eGFR) mutations

  The main purpose of the clinical study is to see how BAY 2927088 will influence the take up, metabolism (chemically broken down), distribution through the body, and excretion of dabigatran etexilate (is a medication than helps preventing dangerous blood clots from forming in the body) and rosuvastatin (is a medication used to lower cholesterol levels and reduce the risk of heart disease and strokes). Additionally, the clinical study aims to see how safe BAY 2927088 is and how well it is tolerated after dosing when given alone and along with dabigatran etexilate and rosuvastatin.
  The trial will comprise of:
  - Screening period of a maximum 28 days
  - In-house Treatment Period- admission on Day-1
  - A stay in the unit for 17 days and 16 nights
  - A Follow up Visit 7 to 10 days after the dose of clinical trial medication

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  24/LO/0026

• Date of REC Opinion

  6 Mar 2024

• REC opinion

  Further Information Favourable Opinion