PK, Bioavailability and Food effect study of Lu AF11167 (QSC201607)
Research type
Research Study
Full title
Interventional, open-label, two-part, partly-randomized study investigating the pharmacokinetic properties, absolute bioavailability, food effect, and intra-subject variability of up to 5 prototype modified-release tablet formulations of Lu AF11167 in healthy subjects
IRAS ID
263308
Contact name
Rachel Smith
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2018-003718-42
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
The Sponsor is developing a new test medicine to treat schizophrenia.
Schizophrenia is a severe long-term mental health condition that causes a range of psychological symptoms and changes how a person thinks and behaves. These include delusions, hallucinations, muddled thoughts, social withdrawal and a lack of emotional expression. The symptoms of schizophrenia can often lead to relationship problems with family and friends.
The study, which is split into 2 parts, will investigate how different formulations (recipes) of the test medicine are taken up by the body and compared to a previously known reference formulation (in Part A), and investigate the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein (in Part B).
In Part A of the study, 18 healthy male volunteers will attend the clinical unit on 6 occasions (periods) to receive up to 5 prototype formulations (recipes) of the test medicine and one reference tablet formulation. There is also the following optional variables in periods 3-6: use of gamma scintigraphy for gastrointestinal tract imaging, dosing under fed conditions, co-administration of an oral solution of the test medicine.
In Part B of the study, 15 healthy female and male volunteers will attend the clinical unit on 3 occasions to receive a selected prototype from Part A under fed and fasted conditions. Additionally on one occasion, volunteers will receive the test medicine as both a tablet to swallow, and as an intravenous (IV) injection directly into the arm.
Volunteers will be discharged from the clinic 48 hours after each dose, and will return for a follow up visit 6 days after their final dose to ensure their continued wellbeing.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0231
Date of REC Opinion
23 Jul 2019
REC opinion
Favourable Opinion