Conditions: Schizophrenia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.

Detailed description:
There were 3 to 4 cohorts of 2 patients per receptor group. Lu AF35700 was administered as multiple oral doses for up to 21 days before the PET scans were performed. The doses in all groups were selected with the aim of characterising the exposure response (occupancy) curve. The doses for all groups, with the exception of A1, B1, and C1, were subject to change within the dose range already investigated and found tolerable. The next dose for the groups was established at a dosing conference based on an evaluation of the occupancy obtained, and safety, tolerability, and pharmacokinetic data from all previous cohorts.

Arms:
arm 1: Up to 3 PET scans, besides baseline scan, using \[11C\]-NNC 112 tracer to detect D1 dopamine receptor occupancy before and after multiple oral dosing of Lu AF35700 arm 2: Up to 3 PET scans, besides baseline scan, using \[11C\]-Raclopride to detect D2 dopamine receptor occupancy before and after multiple oral dosing of Lu AF35700 arm 3: Up to 3 PET scans, besides baseline scan, using \[11C\]- Lu AE60157 tracer to detect 5-HT6 (5-hydroxytryptamine-6) receptor occupancy before and after multiple oral dosing of Lu AF35700

Interventions: intervention 1: Lu AF35700
Intervention descriptions: intervention 1: 5 mg tablets for oral administration

Protocol document: