Investigation of bioavailability and food effect on PK of Lu AF35700
Research type
Research Study
Full title
Interventional, open-label, two-way crossover, single-dose study investigating the absolute bioavailability and food effect on the pharmacokinetics of Lu AF35700 in healthy subjects
IRAS ID
242468
Contact name
Ashley Brooks
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2017-001336-19
Clinicaltrials.gov Identifier
18/NE/0062, REC
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Lu AF35700 is an investigational medicinal product aimed to be helpful in treating people with schizophrenia. Lu AF35700 acts by blocking certain receptors in brain thought to be involved in the disease process.
Lu AF35700 is currently being investigated in a global phase III clinical development
programme.
The aims of this Study are to determine:
• How much of the active component of the Study Drug (the part that causes the effects) gets into the bloodstream and how long it takes the body to remove it.
• How food affects how much of the Study Drug gets into the blood stream and how long it takes the body to remove it.
• The difference between 2 forms of the Study Drug ˗ how each form gets into the blood stream and how long it takes the body to remove it.
• The safety of the Study Drug and any side effects that might be associated with it.
Up to 20 participants are planned to take part in this Study. The intention is to dose 10 participants in each of 2 groups.
The Study will consist of 2 Study Periods in each group: Study Period 1 and Study Period 2. All participants will take part in both Study Periods.
Group 1, in each Study Period, participants will receive a single 20 mg oral dose of the Study Drug in tablet form.
Group 2, in each Study Period, participants will receive a single 20 mg oral dose of the Study Drug in tablet form and in Study Period 1 only, volunteers will also receive a very small dose of the Study Drug as an injection later the same day. The injection will be a mixture of 0.1 mg of the Study Drug which will be made into a 5 mL solution containing radioactive carbon 14 ([14C]-Lu AF35700]). This will allow us to investigate how body handles the Study Drug.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0062
Date of REC Opinion
7 Jun 2018
REC opinion
Favourable Opinion