ADME study of [14C]-BTD-001 in healthy male subjects (QCL117854)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BTD-001 in Healthy Male Subjects
IRAS ID
218424
Contact name
Patricia Walicke
Contact email
Sponsor organisation
Balance Therapeutics, Inc.
Eudract number
2016-004490-40
Duration of Study in the UK
0 years, 0 months, 25 days
Research summary
The Sponsor is developing the study drug, [14C]-BTD-001, for the potential treatment of idiopathic hypersomnia (IH) and narcolepsy which are rare sleep disorders. IH is characterised by excessive sleepiness and narcolepsy causes a person to suddenly fall asleep.
The study will try to identify the amount of radioactivity found in blood, urine and faecal samples after a single dose of the study drug. The study will also aim to provide blood, urine and faecal samples to look at the breakdown products and to find out the structure of these products.
The study will consist of a single part involving up to 6 healthy male subjects. The 6 subjects will receive a dose of 100 mg study drug which is radiolabelled. ‘Radiolabelled’ means that the test drug has a radioactive component which helps us to track where the drug is in the body. Samples of blood, urine and faecal samples will be taken throughout the study to look at the concentrations of the radiolabelled drug in the body.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0126
Date of REC Opinion
23 Mar 2017
REC opinion
Favourable Opinion