Clinical Study: 34234

If you are a healthy male or female (of non-childbearing potential) aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a new drug being developed for the potential treatment of a range of diseases associated with the brain and central nervous system, including schizophrenia.

*Terms & Conditions apply.

Study Payment: £2850

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a drug called MDI-26478.

The overall objectives of the study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration in the blood of the study drug when evaluated in different conditions i.e., different doses and following administration of single and multiple doses. The study also aims to evaluate the effect of the study drug on the body (known as pharmacodynamics), through the performance of different types of cognitive testing (to measure changes in your skills associated with memory, attention and decision making) and specific imaging procedures of the brain.

Blood samples will be taken at set time points throughout the study in order to measure the concentration of MDI-26478 in the blood. In the context of the whole study, we will analyse the results from each of the groups and each study part and combine this information in order to better understand how MDI-26478 works in the body and assess how the levels of MDI-26478 change over time when MDI-26478 is administered at different doses and as single and multiple doses.

MDI-26478 is being developed as a potential treatment for a range of disorders associated with the central nervous system (CNS – brain and spinal cord), including schizophrenia (the main focus for this study).

Part C

The purpose of Part C is to evaluate the study objectives when MDI-26478 is given as a single dose on one occasion at different dose strengths across three treatment periods.

Part C will consist of up to 20 participants with each participant required to complete all three treatment periods. Across the three treatment periods, each participant will receive one lower dose of MDI-26478, one higher dose of MDI-26478 and one dose of placebo (which contains no active drug) in the form of an oral capsule (or multiple capsules dependent on dose strength).

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a period of 3 days (2 overnight stays – Day -1 to Day 2 per treatment period) with each treatment period separated by approximately 5-14 days, followed by a post-study follow-up visit 5-7 days following the last dose of MDI-26478.You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you complete this part of the study, you will receive a maximum inconvenience payment of £2850

up to 2 separate visits

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