Phase 1 study to investigate safety, tolerability, PK and PD of MP-157

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, first time-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of MP-157 in healthy subjects; including the effect of food, gender and age on the pharmacokinetics of a single dose of MP-157 in healthy subjects

• IRAS ID

  71321

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Mitsubishi Pharma Europe Ltd

• Eudract number

  2011-000104-17

• Research summary

  The study is divided in to 5 parts:Part 1 will investigate the safety, tolerability and pharmacokinetics (PK; levels of drug in the blood) of single ascending doses of MP-157 in healthy male subjects. Part 2 will investigate the effect of food on the PK of MP-157 in two treatment periods in healthy male subjects. In each treatment period subjects will be randomly assigned to receive a dose of MP-157 either following an overnight fast or after a high-fat breakfast. Part 3 will investigate the safety, tolerability and PK in healthy female subjects of non-child bearing potential. Part 4 will investigate the safety, tolerability and PK in healthy elderly male subjects. Subjects in Parts 2, 3 and 4 will receive a single dose of MP-157 at dose level previously given to male subjects in Part 1. In Parts 1, 3 and 4 in each group 6 subejcts will receive MP-157 and 2 will receive placebo. Part 5 will investigate the safety, tolerability and PK of multiple oral doses of MP-157. In each group 8 subjects will receive MP-157 and 2 will receive placebo. All subjects will be healthy volunteers aged between 18 and 55 years except in Part 4 where subjects will be 65 years or older. In Parts 1 and 5 the dose levels are planned to be administered in ascending order. Progression to the next dose level, and dose selection, will be based on the safety, tolerability and available PK data from the preceding dose group. Up to three additional groups may be added to Parts 1 and 5 if required.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0047

• Date of REC Opinion

  25 Mar 2011

• REC opinion

  Further Information Favourable Opinion