Clinical Study 36342

If you are a healthy male or female aged between 18 and 55, then you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of a range of diseases associated with the brain and central nervous system, including major depressive disorder (MDD).

Study Payment* £2,600.

Apply for this study

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Study Payment: £2,600

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By agreeing to this form and selecting the box as outlined on your application, you are confirming that you have read the information provided in our data protection and consent policy, and give your consent for Simbec-Orion to record and retain your personal and special categories of data for the purposes and duration(s) stated above.

Please confirm that you have read these terms and understand that Simbec-Orion will be holding and processing your personal and special categories of data for the purposes stated above.

Simbec-Orion are also required to process your bio-metric data (a photograph only when you attend an onsite screening visit), we do this to ensure we can identify you for security purposes. We do not share this data with any other third-party, we solely use this data for the purpose of recognition. For the completion of your enrolment and part of your eligibility, we are required to collect this data. By selecting the box below, you also explicitly consent to the use of your bio-metric data as and when it is collected.

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Thank you for your time and interest, but unfortunately based on your answer, you are not eligible to apply for this study.

please check out our other studies to see if you may be eligible to apply for one of those.

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Study Information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate the study drug, DT-101. The main objectives of the study are as follows; to determine the safety and tolerability of DT-101 when it is administered as a single dose on two occasions; once in a fasted state (without food) and once in a fed state (following a high-fat, high-calorie meal). To investigate the concentration of DT-101 in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentrations when DT-101 is administered in a fasted state and fed state known as food effect.

Blood samples will be taken at set time points throughout the study in order to measure the concentration of DT-101 in the blood. In the context of the whole study, we will evaluate the results from each treatment period to determine if there are any significant differences in the safety profile of DT-101 or the concentration of DT-101 in the blood as a result of taking DT-101 with or without food. The purpose of the data generated in this study is to provide further information and guidance to support the study Sponsor in the development of the study drug, DT-101.

DT-101 is being developed as a potential treatment for a range of disorders associated with the central nervous system, including major depressive disorder – MDD (the main focus for this study). Currently, there are limited treatment options available for this condition which are considered long term and effective and there are no known cures. Therefore, there is an unmet need to develop potential new treatments which could be more effective.

The study will consist of 15 participants with each participant required to complete both treatment periods. Across the two treatment periods, each participant will receive:

a single dose of DT-101 (18 milligrams (mg)) in the form of an oral capsule following an overnight fast,
a single dose of DT-101 (18 mg) in the form of an oral capsule following a high-fat, high-calorie meal.

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Further Information

The purpose of the study is to evaluate the study objectives when DT-101 is given as a single dose on two occasions in the presence and absence of food across two treatment periods.

If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period 2 overnight stays, from admission on Day-1 to discharge on Day 2, for each treatment period (two treatment periods minimum).

If you participate in this study, you will be required to complete an outpatient visit on Day 3 of each treatment period.

One follow-up visit is required approximately 5-7 days following the last dose on treatment period 2 only.

Each dose in each treatment period will be separated by a minimum period of 4 days; however, this period may be longer (up to a maximum of 14 days) so you will be informed during the course of the study if this is the case and subsequently, when you will need to return to complete the second treatment period.

You should ensure that you are able to commit to completing all visits before agreeing to participate in this study and have sufficient flexibility to accommodate any revisions in the timing of the second treatment period as applicable.

If you complete this study, you will receive a maximum inconvenience payment of £2600.

Screening Visit
Day -35 to Day -2

Treatment Period 1
Day -1 to 2

Outpatient Visit
Day 3

Washout Period
Minimum of 4 days

Treatment Period 2
Day -1 to 2

Outpatient Visit
Day 3

Post Study Follow Up Visit
5-7 days following last dose

Apply Now. Be Amazing

If you are a healthy male or female aged between 18 and 55, then you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of a range of diseases associated with the brain and central nervous system, including major depressive disorder (MDD).

Study Payment* £2,600.

Your details

Study Information

Let's get started