PRB-01022 SAD/MAD study

• Research type

  Research Study

• Full title

  PRB-01022 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy and Dyslipidemic Male and Female Subjects

• IRAS ID

  79569

• Sponsor organisation

  Pronova BioPharma Norge AS

• Eudract number

  2011-001917-15

• Research summary

  PRB-01022 is a new drug being developed for the treatment of hypertriglycerideamia (high levels of fatty molecules within the blood). This study will be the first time that the drug is given to humans. The study is divided in to 3 parts: Part 1 will investigate the safety, tolerability and pharmacokinetics (PK; levels of drug in the blood) of single doses of PRB-01022. Eight subjects in each of six groups will receive single doses of PRB-01022 or placebo. In each group two subjects will receive placebo, the rest will receive PRB-01022. Each subject will take part in one treatment period. Part 2 will investigate the effect of food on the PK of PRB-01022. Eight subjects will take part in two treatment periods. At the first treatment period subjects will be randomly assigned to receive a dose of PRB-01022 following an overnight fast or after a high-fat breakfast. At the second treatment period subjects will receive a dose under the alternate condition. No subjects will receive placebo in this group. Part 3 will investigate the safety, tolerability and PK of multiple oral doses of PRB-01022. Eight subjects in each of three groups will receive multiple oral doses of PRB-01022 or placebo. In each group two subjects will receive placebo, the rest will receive PRB-01022. Subjects in part 3 of the study will have high levels of triglycerides (= 1.7 mmol/L) and high LDL cholesterol (= 2.5 mmol/L) in their blood, but will be otherwise healthy. Each subject will take part in one treatment period. All subjects will be aged between 18 and 55 years. All doses will be administered orally. In parts 1 and 3 following review of data from earlier groups, it is intended that the dose level will increase between each group.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0118

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Favourable Opinion