Study to Investigate PK of Novel Formulations of MK-0518 (QBR114250)

• Research type

  Research Study

• Full title

  A Product Value Enhancement (PVE) Study to Investigate the Pharmacokinetics of Novel Controlled Release (Immediate Release / Gastroretentive) Formulation(s) of MK-0518 (Raltegravir)

• IRAS ID

  114362

• Contact name

  Philip Evans

• Sponsor organisation

  Merck and Co. Inc

• Eudract number

  2012-003725-16

• Research summary

  The Study will look at the pharmacokinetics (how the drug is taken up and broken down by the body) of a once daily dose of MK-0518 in a prototype tablet. A new formulation of the study drug MK-0518 (the study drug) is being developed by the sponsor, Merck and Co Inc. The current formulation of this drug is called ISENTRESS© and is marketed for use in the treatment of HIV-1 infection in adult patients. This study aims to look at the way in which different forms of the study drug are released and taken up by the body, to hopefully achieve a level of the study drug, in the body, that could be achieved by a once daily dose as opposed to the twice daily dose which is currently approved. In this study, 24 healthy male or female subjects will receive a single oral dose of 1500 mg MK-0518 (as 2 trilayer tablets) on up to four separate occasions. Blood samples to examine the pharmacokinetics of the drug will be performed before dosing and up to 48 hours post-dose.

• REC name

  HSC REC B

• REC reference

  12/NI/0152

• Date of REC Opinion

  2 Nov 2012

• REC opinion

  Further Information Favourable Opinion