Phase 1 pharmacoscintigraphic study of centanafadine (QSC201589)
Research type
Research Study
Full title
A Single-Centre, Open-Label, Phase 1, Pharmacoscintigraphic Study in up to Two Parts Designed to Evaluate the in vivo Performance of Centanafadine Following Single-Dose Administration of Modified Release Centanafadine Prototype Capsules in Healthy Subjects
IRAS ID
271217
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc
Eudract number
2019-003326-25
Duration of Study in the UK
0 years, 5 months, 22 days
Research summary
The Sponsor is developing the test medicine, Centanafadine, for the potential treatment of attention-deficit hyperactivity disorder (ADHD). ADHD is a behavioural disorder that includes symptoms such as inattentiveness, hyperactivity and impulsiveness. These symptoms may lead to a person with ADHD having difficulty at school, work and in everyday life.\n\nIn current clinical trials, the test medicine is taken two or more times per day. In this study, the sponsor is investigating different recipes (formulations) of the test medicine in the form of a capsule with the aim of finding a recipe which is absorbed slowly by the body and therefore only needs to be taken once a day. This may be achieved by a combination of capsule formulations dosed simultaneously. \n\nThe study will consist of up to 2 parts, involving up to 28 healthy male and female volunteers. \nIn Part 1, 16 healthy male and female volunteers will be enrolled into 2 cohorts to attend the clinical unit for 5 visits (periods). At each period, volunteers will receive a single dose of the test medicine as capsules to swallow in a fasted state. For the first two periods, volunteers in cohort 1a will also receive a capsule containing beads radiolabelled with 111In.\n\nPart 2 is optional and will only be performed if an acceptable mixture of the formulations tested in Part 1 is achieved. 12 volunteers will attend the clinical unit for two periods to receive a combination of the test medicine formulations selected from part 1 in the fed and fasted states. The contents of the capsules may be sprinkled on food.\n\nIn both parts, volunteers will be discharged 48 hours after each dose, and will have a follow up call 5 to 7 days after their final dose to ensure their continued wellbeing.\n\n
REC name
Wales REC 2
REC reference
19/WA/0245
Date of REC Opinion
12 Sep 2019
REC opinion
Favourable Opinion