ITF2984 (QBR110527)

• Research type

  Research Study

• Full title

  A Within Group, Randomised, Phase I, Repeated Doses, Placebo and Octreotide Controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics after Incremental Doses of ITF2984

• IRAS ID

  91668

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Italfarmaco S.p.A

• Eudract number

  2011-003526-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is designed to investigate safety and tolerability and the pharmacokinetic (how the drug is absorbed by the body) effects of repeated doses of ITF2984, and also to assess the effect of ITF2984 on pharmacodynamic (what the drug is doing to the body) biomarkers of various hormone levels after exogenous stimuli (triggers outside of the body's processes) in healthy male subjects.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0165

• Date of REC Opinion

  22 Nov 2011

• REC opinion

  Further Information Favourable Opinion