SAD and MAD safety assessment of Rec 27/1819 in healthy volunteers.

• Research type

  Research Study

• Full title

  A phase I, double-blind, randomised, parallel groups, placebo controlled study to assess the safety, tolerability and pharmacokinetics in (A) single ascending doses and (B) multiple ascending doses of oral Rec 27/1819 administered in healthy volunteers

• IRAS ID

  112184

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Recordati S.p.A

• Eudract number

  2012-003360-42

• ISRCTN Number

  xx

• Research summary

  We are conducting a clinical trial sponsored by Recordati S.p.A at our research centre with an investigational medicine called REC 27/1819 which may help to treat symptoms of lower urinary tract diseases such as overactive bladder (OAB). This is the first time REC 27/1819 will be given to humans but other medications which work in a similar way to REC 27/1819 have been given to humans previously. The study is designed in two parts:- Part A and Part B. Part A will investigate a Single Ascending Dose (SAD) in 24 healthy volunteers (12 young and 12 middle aged) and Part B will investigate Multiple Ascending Doses (MAD) in 36 middle-aged healthy volunteers. The study will be conducted using an Adaptive Design. Volunteers will attend our clinical unit for 4 visits including 1 screening visit and 3 residential visits (Part A) or 2 visits including 1 screening visit and 1 residential visit for Part B but volunteers will be involved in the study for approximately 8 weeks in total while we assess their suitability for the study and conduct the study and follow-up at the end of the study. In order to be included in the study, volunteers must be healthy male or female Caucasians, 18-64 years of age, with a BMI of 18-30kg/m2 inclusive. During the study, volunteers will receive a single (Part A) or multiple (Part B) oral doses of REC 27/1819. The study procedures will include physical examination, medical history, blood and urine tests, alcohol breath test, ECGs, vital signs assessments and collection of blood samples for analysis of REC 27/1819. The study is sponsored by Recordati S.p.A, who are the manufacturers of REC 27/1819.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1342

• Date of REC Opinion

  3 Sep 2012

• REC opinion

  Favourable Opinion