First in Man Study of LCF369

• Research type

  Research Study

• Full title

  A first-in-man, single centre, assessor-blind, active, vehicle and no-intervention controlled study to evaluate safety and local tolerability, pharmacodynamics, systemic and skin exposure after multiple topical application of LCF369, a stearoyl-CoA desaturase-1 inhibitor, in healthy volunteers with oily skin

• IRAS ID

  18288

• Sponsor organisation

  Novartis AG

• Eudract number

  2009-009499-11

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to determine if two strengths of a new drug called LCF369 are suitable for use on the skin (safe and tolerable), to find out how much of the study drug crosses the skin into the blood by measuring drug levels in the blood (pharmacokinetics) and to assess the effects on sebaceous glands within the skin (efficacy) and to assess the effect on the production of sebum (oil produced by skin) (efficacy). A screening visit will be conducted to determine if the volunteer is eligible. This will be conducted from -21 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 LCF369 and a standard treatment on pre-determined sites on the upper back for 13 days and a single application on day 14. Volunteers will be required to stay in the clinical unit for 15 nights where skin assessments will be conducted to assess tolerability. Blood samples will be taken from volunteers to assess the systemic exposure of LCF369. Skin biopsies will be taken to assess the amount of drug in the tissue and to assess effects on sebaceous glands.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 6 - 8 days following the last application of the study drug.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/19

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Favourable Opinion