Three part study investigating Letermovir in healthy female volunteers

• Research type

  Research Study

• Full title

  A single centre, 3-part trial to investigate (A) the safety, tolerability and pharmacokinetics of multiple ascending oral doses and (B) multiple intravenous doses of letermovir, and (C) the effect of letermovir under steady state conditions on the pharmacokinetics of a single oral dose of digoxin, a sensitive P-glycoprotein substrate

• IRAS ID

  91238

• Contact name

  Ulrike Lorch

• Sponsor organisation

  AiCuris GmbH & Co. KG

• Eudract number

  2011-004516-39

• Research summary

  Current drugs used to prevent and treat human cytomegalovirus (HCMV) infection are toxic at higher doses and may affect kidney and bone marrow function in some patients. AiCuris GmbH & Co. KG is developing a new drug called letermovir, which is anticipated to be safer than current marketed drugs as it works in a different way. Letermovir is being developed as an oral tablet as well as an intravenous infusion for very ill patients who cannot swallow. The main purpose of the trial is as follows:Part A ?? to establish whether higher doses can be given safely to patients who are taking other drugs such as cyclosporine A and who may therefore have higher levels of letermovir in their blood than expected.Part B ?? to determine suitable (effective and safe) repeated doses that can be given to patients intravenously. Part C ?? to investigate any potential interaction of letermovir with other drugs which patients may be taking by using digoxin (Lanoxin©) as a probe (drug approved by FDA for testing such drug-drug interactions). The trial will involve 74 healthy female volunteers (in total) of any ethnic origin and will be conducted at a single site Clinical Trial Unit. Part A and Part B will last for approximately 48 days and Part C will last for approximately 70 days.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0163

• Date of REC Opinion

  27 Oct 2011

• REC opinion

  Further Information Favourable Opinion