QBR111431 (CT5004)

• Research type

  Research Study

• Full title

  An open-label, non-randomised monocentric Phase I study evaluating the pharmacokinetic profile of novel formulations of RhuDex®

• IRAS ID

  87056

• Contact name

  Stuart J Mair

• Sponsor organisation

  MediGene AG

• Eudract number

  2011-002996-40

• Research summary

  RhuDex© is in development for autoimmune diseases e.g. rheumatoid arthritis. The target is for it to be an orally administered drug. The target product is a once daily oral formulation, which achieves blood concentrations of between 2000 ?? 3000 ng/mL within approximately 1 week of dosing. Two prototype oral lipid formulations have been identified as having the potential to overcome some of the limitations seen in previous formulations of the drug and achieve the target product profile.The objective of the current study is firstly to identify which formulation platform provides the most appropriate levels of the drug in the blood and secondly, to optimise that formulation. Additionally in part 2 of the study, the dose level of the drug can be changed and also dosed with food to look at the effects of these factors.

• REC name

  Scotland A REC

• REC reference

  11/IE/0149

• Date of REC Opinion

  12 Oct 2011

• REC opinion

  Further Information Favourable Opinion