Pilot to investigate the bioavailability of LB03002

• Research type

  Research Study

• Full title

  A Pilot Study Investigating the Bioavailability of LB03002 Manufactured From Two Different Manufacturing Production Lines in Male Adult Volunteers

• IRAS ID

  85754

• Sponsor organisation

  LG Life Sciences Ltd.

• Eudract number

  2011-003434-14

• Research summary

  The LB03002 drug product has been manufactured in the manufacturing process (Production Line 1). In anticipation of a need for larger capacity and more efficient manufacturing process, the sponsor has established an alternative scale-up manufacturing process (Production Line 2). In further support of comparable product quality and functionality, a single-dose BE study is also being planned in support of the manufacturing change. To design the adequate bioequivalence study, this pilot study is to explore the bioavailability of LB03002.This will be a two treatment periods study, with 12 non-smoking volunteers. Volunteers will undergo a screening visit, followed by a residential period from Day -1 through to Day 2 and Day 22 to Day 24. Subjects will attend the clinical unit for their PK and PD blood samples on Days 4, 5, 6, 7, 8, 26, 27, 28, 29, and 30. There will be a follow up visit on Day 32. Subject will receive a single subcutaneous dose of study drug on the morning of Day 1 and Day 23. Subject will also receive a single subcutaneous dose of somatostatine analogue, octreotide one hour prior to the dose of the study drug and repeated every 8 hours on Day 1 and Day 23.Safety will be assessed on this study through the measurement of vital signs, electrocardiograms, physical examination and safety blood samples.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0121

• Date of REC Opinion

  31 Aug 2011

• REC opinion

  Further Information Favourable Opinion