A Phase 1 AME Study with 14C-Ecopipam
Research type
Research Study
Full title
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam Following a Single Oral Capsule Dose in Healthy Male Subjects
IRAS ID
289014
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Emalex Biosciences, Inc
Eudract number
2020-005041-16
Clinicaltrials.gov Identifier
20/NE/0221, Rec Ref
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
The planned study is for an investigational drug that is being developed by the study sponsor as a potential treatment for Childhood Onset Fluency Disorder and Tourette syndrome.
Stuttering is not an uncommon disease of childhood and is seen in up to 5% of children. Approximately 80% to 90% of stuttering will start by around 6 years of age, most of which will ultimately recover around the age of 16 years, some cases of stuttering however continue into adulthood. There are no approved pharmacologic therapies for this condition, and as a result, there remains a large unmet medical need for safe and effective treatments for stuttering.
Tourette syndrome is a neurological condition characterised by motor or vocal tics that begin in childhood and can persist over time. Onset of tics is seen early in childhood and peaks in teenage years. Approximately 50% of patients have full resolution of symptoms as they mature into adulthood. A more selective drugthan those currently available may be a safer alternative.
The planned study will be conducted at a single research centre (Covance Clinical Research Unit Ltd, Leeds).
8 eligible subjects will be admitted into the Clinical Research Unit (CRU) on Day -1 and be confined to the unit until at least Day 8 (Discharge). On Day 1, subjects will receive a single oral dose of 200 mg ecopipam hydrochloride containing carbon-14 which is a naturally occurring radioactive form of carbon to allow the study drug and its breakdown products to be measured in the blood, urine, and faeces.
This will allow different parts of the study drug to be traced after it has been broken down by the body.
Participation in the study is expected to last up to a maximum of 6 weeks.
Subjects will be discharged after set radioactivity discharge criteria have been met.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0221
Date of REC Opinion
11 Dec 2020
REC opinion
Favourable Opinion