Multiple Ascending Dose to assess DF 2156A

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DF 2156A in Healthy Male Volunteers

• IRAS ID

  79465

• Contact name

  Simon Singer

• Sponsor organisation

  Dompé s.p.a

• Eudract number

  2011-000751-16

• Research summary

  This will be a multiple ascending dose study of DF 2156A in healthy male subjects. The study will provide a greater safety margin before proceeding to proof of concept studies. There will be 2 cohorts with 12 subjects planned in each cohort.Volunteers will undergo a screening visit, two additional screening visits to conduct holter monitoring for assessment of heart rhythm followed by a residential period from Day -1 through to Day 11, a follow up visit will be performed 7 days after discharge.A single oral dose of DF 2156A or matched placebo will be given on Day 1 and Day 8, on days 3 through 7 volunteers will be administered the dose twice daily. The dose of DF 2156A will be escalated in the second cohort in order to obtain the safety and PK information. The planned dose levels are 300mg and 400mg for the cohort 1 and 2 respectively.Safety will be assessed on this study through the measurement of vital signs, electrocardiagrams, physical examinations and safety blood samples.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0076

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion