Study 36057

If you are a healthy male or female aged between 18 and 55 or 65 and over, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of Parkinson’s Disease (PD).

*Terms & Conditions apply.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a multi-part study to investigate this study drug.

The overall objectives of this study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and drug levels in the blood, urine and cerebrospinal fluid (CSF) when the study drug is given in different conditions e.g., following administration of different dose strengths, single and multiple doses and following optional evaluations which may include; in the presence and absence of food, effects associated with age, evaluating how the drug is distributed in the body (through using specialist imaging techniques) and evaluating these effects when the drug is administered in the patient population which the study drug is intended to treat.

The study drug is being developed for the potential treatment of Parkinson’s Disease (PD) which is a long-term progressive condition of the nervous system (which means it  gets worse over time) whereby there is an accumulation of proteins in certain cells in the brain, leading to death of these cells and is associated with symptoms like uncontrollable shaking and difficulty with balance and coordination. Despite the development of effective therapies for PD, these treatments only serve to manage the symptoms associated with PD and do not actually address the underlying causes of the disease. Therefore, there is an unmet need to develop therapies which seek to target the underlying causes of the disease. This study will be split into up to five separate parts, and you will only participate in one part of the study.

Part 1

The purpose of Part 1 is to evaluate the study objectives when the study drug is administered as a single dose at increasing dose strengths.

In addition in this study part, one group in Part 1 may investigate the effect of food on the study drug by taking a single dose of the study drug following an overnight fast and then following a high fat meal and some of the groups may investigate the levels of the study drug which are found in the CSF following completion of a lumbar puncture procedure. Part 1 will consist of one group of 6 participants up to 6 planned groups of up to 8 participants: each group will evaluate a different dose of the study drug starting at the lowest dose and gradually increasing in each group. This is known as a single ascending dose (SAD) study. Each participant in each group will either receive the study drug or a placebo (which contains no active drug) in the form of an oral capsule(s).

If you participate in this part of the study and are in the groups which are not undertaking the evaluations of food effect or measuring CSF i.e., only completing one treatment period, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 4 days (3 overnight stays) for the treatment period (Day -1 to Day 3), a return visit on Day 4 (if required), followed by a post study follow-up visit approximately 10 days following the dose of the study drug on Day 1.

If you participate in this part of the study and are in one of the groups completing the evaluations of food effect or measuring CSF i.e., completing two treatment periods, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 4 days (3 overnight stays) in each treatment period, complete up to two return visits on Day 4 of each treatment period (if required), followed by a follow-up visit approximately 10 days following the last dose of the study drug Day 1 in treatment period 2. Each dose in each treatment period will be separated by a period of 1-2 weeks; however this period may be longer so you will be informed as to whether you are participating in one of these groups and in addition, when you will need to return to complete the second treatment period.

You should also note that the timing of the post-study follow up visit may be extended if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place). Regardless of which group you are participating in, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you are participating in the standard groups within Part 1 i.e., only completing one treatment period or you choose not to participate in the food effect and CSF groups (if your group is selected for these evaluations) and you complete this part of the study, you will receive a maximum inconvenience payment of £1775. If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3250. If you are in one of the CSF sampling groups i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3750.

For all groups in Part 1, you will be required to stay at the clinical unit for a maximum of 3 overnight stays per treatment period and if you are invited to complete the second treatment period, then the gap between the two doses in each treatment period will be approximately 1-2 weeks in duration. You will be informed as to whether your study group has been selected for either of the evaluations requiring completion of the second treatment period and therefore how long the study will be for you (including providing details of when you will need to return to complete the second treatment period as applicable). You should ensure that you are available to complete all required visits before agreeing to participate in the study.

In addition, the timing of the post-study follow up visit may be extended for all groups (with the exception of Group 1) if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place).

If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3250.

If you are in one of the CSF sampling groups i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3750.

Part 1 Period 2A

The purpose of Part 1 – Treatment Period 2a is to evaluate the study objectives when the study drug is administered as a single dose at a selected dose strength which has already been evaluated in Part 1.

This treatment period will consist of up to 16 participants and may comprise of participants who have previously participated in another Part 1 group or new participants who have not previously participated in the study. In this part of the study, each participant will receive the study drug in the form of an oral capsule(s).

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 4 days (3 overnight stays) for the treatment period (Day -1 to Day 3), a return visit on Day 4 (if required), followed by a post study follow-up visit approximately 10 days following the dose of the study drug on Day 1. You should ensure that you are able to commit to completing all visits before agreeing to participate in this study. You should also note that the timing of the post-study follow up visit may be extended if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place).

If you are participating in this group within Part 1 and you complete this part of the study, you will receive a maximum inconvenience payment of £2775.

You will be required to stay at the clinical unit for a maximum of 3 overnight stays for the treatment period and therefore, you should ensure that you are available to complete all required visits before agreeing to participate in the study.

In addition, the timing of the post-study follow up visit may be extended if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place).

If you are participating in this group within Part 1 and you complete this part of the study, you will receive a maximum inconvenience payment of £2775.

Study Payment: £1775 to £4850 Apply. Be amazing

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