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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Phase 1 study in healthy volunteers of a treatment to improve and/or normalize symptoms and deficits in patients with Fragile X Syndrome (FXS)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This is a study of AUT00206 (the study medicine), an experimental new medicine with the potential to treat Fragile X syndrome. We’re doing this study to find out the blood levels and side effects of the study medicine in healthy volunteers (both men and women).
Background of the disease: Fragile X syndrome (FXS) is the most common inherited cause of learning disability, affecting about 1 in 7000 boys and men, and 1 in 11,000 girls and women. It causes a wide range of problems with learning and behaviour. Currently, there are no medicines that specifically treat FXS. AUT00206 (the study medicine) is an experimental new medicine for treating FXS. It acts at sites on nerve cells (called voltage-gated potassium channels) that help to control electrical signalling in parts of the brain involved in learning and behaviour. So, we hope it will be a useful treatment for FXS.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Funder report results see attached file 40474 Funder report V1 04Oct2022.pdf [1] (added 14/11/2022)
You can take part if:
You may not be able to take part if:
1. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a highly-effective method of contraception.2. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.3. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous.4. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, post-COVID-19 syndrome (‘long COVID’), or history of any psychotic mental illness.5. Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.6. Presence or history of severe adverse reaction to any drug, or a history of sensitivity to AUT00206 or its excipients.7. Use of a prescription medicine (except oral contraceptives in females) during the 30 days before the first dose of trial medication, or use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication.8. Use of vaccine (including COVID-19 vaccine) during the 7 days, before first receipt of trial medication until the end of the study.9. History of epilepsy or seizures.10. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before [first] admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.11. Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly.12. Smoking of more than 5 cigarettes daily.13. Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90–140 mm Hg systolic, 40–90 mm Hg diastolic; heart rate 40–100 beats/min.14. QT value, measured at screening visit, greater than 450 msec (men) or 470 msec (women) on 12-lead ECG, using Fridericia’s formula (QTcF) for correction. 15. Alanine aminotransferase (AST), aspartate aminotransferase (ALT) or alkaline phosphatase (AP) ≥ 1.5 x the upper limit of normal (ULN). A repeat is allowed on one occasion for determination of eligibility.16. Possibility that the volunteer will not cooperate with the requirements of the protocol.17. Positive test for hepatitis B, hepatitis C or HIV consistent with ongoing infection.18. Vegans or people who are on a restricted diet for medical reasons (eg lactose intolerant); or unwilling to eat a high-fat breakfast (Part A1 and A2 only).19. Positive result for suicidal ideation or behaviour using the C-SSRS, including a positive response to items 3 to 5; or a history of suicidal behaviour in the past year20. Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.21. Medical objection by General Practitioner (GP) to volunteer entering trial.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Alice
Sharman
-
Alice.Sharman@autifony.com
The study is sponsored by Autifony Therapeutics (United Kingdom) and funded by Autifony Therapeutics Ltd.
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