MK-7655 — first doses in humans; version 1

• Research type

  Research Study

• Full title

  A study to evaluate the safety, tolerability and pharmacokinetics of intravenous single doses of MK-7655 and intravenous single and multiple doses of MK-7655 dosed in combination with Primaxin® IV

• IRAS ID

  36723

• Contact name

  Steve Warrington

• Sponsor organisation

  Merck Sharp and Dohme Ltd

• Eudract number

  2009-011490-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is the first study of a new medicine designed to make penicillin-type antibiotics more effective against resistant bacteria. We hope that the study medicine will be given to patients in combination with an antibiotic that's already prescribed by doctors in the UK. In this study, We'll give up to 48 healthy men (aged 18-45 years) increasing single doses of the study medicine, first alone and then in combination with a marketed antibiotic; and increasing repeated doses of the study medicine in combination with a marketed antibiotic. We'll give the study medicine and the marketed antibiotic directly into the bloodstream, by a slow injection into a vein. Some participants will get dummy medicine instead of the study medicine - neither they nor we will know which one they've been given. We'll assess the side-effects and blood levels of the study medicine and the marketed antibiotic. Participants having single doses will be in the study for up to 13 weeks. They'll have: 6 study sessions, and stay on the ward for 2 nights in each session; and 2 outpatient visits. Participants having repeated doses will be in the study for up to 7 weeks. They??ll have: 1 study session and stay on the ward for 8 nights; and 2 outpatient visits. A pharmaceutical company is funding the study, which will take place at 1 centre in London. We'll recruit healthy participants by: advertising in newspapers and on websites; by word of mouth; and from our volunteer database.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  09/IEC04/1

• Date of REC Opinion

  3 Dec 2009

• REC opinion

  Favourable Opinion