Safety, Tolerability & PK of LDE225 (Final 6 Nov 08)

• Research type

  Research Study

• Full title

  A double-blind, randomized, vehicle-controlled first-in-man study to evaluate the safety, local tolerability and pharmacokinetics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) in healthy volunteers

• IRAS ID

  11605

• Sponsor organisation

  Novartis AG

• Eudract number

  2008-005505-19

• ISRCTN Number

  111

• Research summary

  LDE225 is a novel compound being developed for the treatment of basal cell carcinoma (BCC). Currently the only treatment for BCC is surgery intervention. This is the first administration of this compound to human. This study will assess the safety and tolerability of LDE225 when applied to healthy human skin. The study will also assess how much LDE225 gets into the blood system.A screening visit will be conducted to determine if the volunteer is eligible. This will be conducted from -28 days to -2 days before the first dose of study drug.If eligible the volunteer will enter the study and will receive twice daily applications of LDE225 on pre-determined sites on the forearms. Volunteers will be required to stay in the clinical unit for 14 nights where skin assessments will be conducted to assess tolerability. Blood samples will be taken from volunteers to assess the systemic exposure of LDE225.Assessments of blood pressure and ECg will also be made at pre-determined points during the study. A follow-up visit will be conducted between 3 - 5 days following the last application of the study drug.

• REC name

  Wales REC 1

• REC reference

  08/WSE04/85

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion