Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants

This is an open-label (physicians and participants know the identity of the assigned
treatment), parallel-group, multiple-dose, multicenter study to assess pharmacokinetics
(what the body does to the medication) of five antipsychotics (APS) drugs: aripiprazole,
olanzapine, paliperidone, quetiapine and risperidone in psychiatric participants who are
receiving stable doses of these drugs for the treatment of their disease.

Pharmacokinetics data will be generated from venous and fingerstick-based capillary plasma
concentrations of the drugs and their metabolites. The total number of enrolled participants
in this study will be at least 265. Seventy-five participants will be enrolled for the
aripiprazole, olanzapine and quetiapine cohorts (groups) each, and 20 participants will be
enrolled for the paliperidone and risperidone cohorts each. In aripiprazole, olanzapine and
quetiapine cohorts there will be two subgroups. Subgroup one, 20 participants for
fingerstick capillary + venous blood sampling and subgroup two, 55 participants for only
venous sampling. Paliperidone and risperidone cohorts will be subjected only to capillary +
venous blood sampling.

The study will consist of a screening phase (within 21 days before Day 1) followed by a
3-day observation phase (Day 1 to Day 3). Participants will be admitted to the study center
in the evening of Day -1 and will remain in the study center until discharged on Day 3 after
completion of the last study-related procedure. During the observation phase, the
administration of the prior antipsychotic medication will continue at a participant's usual
dose and dosing schedule, under direct observation of the study staff. There will be no
modification of the participant's medication during the study. Safety will be evaluated
throughout the study and a mandatory pharmacogenomic blood sample will be collected for
analysis of genes that may influence exposure of the APS studied.

Inclusion Criteria:

- Must be clinically stable as per the investigator's judgment (no suicidal behavior or
current significant suicidal judgment based on C-SSRS rating scale)

- No hospitalization for exacerbation of psychiatric symptoms during 3 months before
screening

- Receiving treatment with aripiprazole, olanzapine, paliperidone, quetiapine or
risperidone, or their combination before the study

- Must have body mass index between 17 and 40 kg/m2 (inclusive), and body weight not
less than 47 kg

- Except for the indication for which the antipsychotic treatment is given, generally
healthy with no clinically significant or unstable medical problems

- Must be able to give informed consent

Exclusion Criteria:

- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at
screening as determined by the investigator

- Administering of strong inhibitors or inducers of CYP3A4, CYP2D6 enzymes, like
fluoxetine

- History of or current clinically significant (particularly unstable) medical illness
other than the indication

- Donated blood or blood products or had substantial loss of blood (more than 450 mL)
within 3 months before Day -1

- Lack of 6 suitable puncture sites for capillary blood draws