3-part study investigating Debio 1036 in healthy subjects (QBR112056)

• Research type

  Research Study

• Full title

  A Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses, the Effect of Food, the Absolute Bioavailability and the Metabolite Profile at a Single Dose (Part 1), Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses (Part 2) of Debio 1036 and the Potential Clinical Drug-Drug Interaction (Part 3, optional) in Healthy Male and Female Subjects

• IRAS ID

  107607

• Contact name

  Stuart Mair

• Sponsor organisation

  Debiopharm SA

• Eudract number

  2012-002072-14

• Research summary

  The Sponsor is developing the study drug, Debio 1036, for the potential treatment of autoimmune and inflammatory diseases, such as rheumatoid arthritis, atherosclerosis, multiple sclerosis, inflammatory bowel disease, and systemic lupus erythematosus (known as lupus).The study will dose Debio 1036 to various cohorts of healthy male and female subjects, over 3 seperate study parts: - Part 1 will evaluate the safety, tolerability and pharmacokinetics (how well the drug is absorbed into the bloodstream) of single ascending doses of Debio 1036, and the effect of food, absolute bioavailability (how much drug is present in the blood stream) and the metabolite profile (how the drug is broken down) of a single dose of Debio 1036; - Part 2 will evaluate the safety, tolerability and PK of multiple ascending doses of Debio 1036; - Part 3 will assess the potential clinical drug interaction of Debio 1036 with simvastatin.

• REC name

  HSC REC A

• REC reference

  12/NI/0096

• Date of REC Opinion

  30 Jul 2012

• REC opinion

  Further Information Favourable Opinion