Comparison of 3 BMS-927711 prototype tablet formulations (QBR113051)

• Research type

  Research Study

• Full title

  Protocol CN170-012: Study of Three BMS-927711 Prototype Formulations Either in the Presence or Absence of Famotidine-Induced Gastric Acid Suppression in Comparison with Free Base Capsule in Healthy Subjects

• IRAS ID

  110814

• Contact name

  Philip Evans

• Sponsor organisation

  Bristol-Myers Squibb Research and Development

• Eudract number

  2012-002033-12

• Research summary

  The Sponsor is developing the study drug, BMS-927711, for the potential treatment of migraine. The study will try to identify the relative oral bioavailability (how effectively the drug is made available in the bloodstream when taken orally) of the three tablet test formulations compared with the free base capsule product. This study will dose single administrations of BMS-927711 at 150 mg to healthy male and female subjects over 5 study periods. In Period 1, all subjects will be dosed with the reference free base capsule. In Periods 2-5, they will be dosed with the remaining treatments in a random order: either Prototype 1 in the presence and absence of famotidine, and Prototypes 2 and 3 in the presence of famotidine. Famotidine is a marketed medicine in the UK and will be used to suppress stomach acid production to assess absorption in this environment. It will be administered at a dose of 40 mg orally, 2 hours before dosing with BMS-927711. This is an approved dose level in the UK.

• REC name

  HSC REC A

• REC reference

  12/NI/0111

• Date of REC Opinion

  10 Aug 2012

• REC opinion

  Further Information Favourable Opinion