Objectives

Primary

Pharmacokinetics of XXXXX and its metabolite inplasma following administration of once weeklyXXXXX tablets in the fasted state and after a highfat meal.

Secondary

Safety and tolerability of XXXXX followingadministration of once weekly XXXXX

Ratings

Abnormal Involuntary Movement Scale (AIMS)Simpson-Angus Neurologic Rating Scale (SAS)Barnes-Akathisia Rating Scale (BARS)Clinical Global Impression Severity Scale (CGI-S)Clinical Global Impression for Severity of Suicidality(CGI-SS)Columbia Suicide ScaleEpworth Sleepiness Scale (ESS)

Lab Assessments - 43 per subject

Screening

Day -3: Pre-dose, 12, 24, 36, 48 and 60 hours

Day 1: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72,96, 120, 144, 168 hours

Day 8: Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72,96, 120, 144, 168 hours

ECGs

Screening

Day 1: Pre-dose, 3, 5, 8 and 24 hr

Day 8: Pre-dose, 3, 5, 8 and 24 hr

• Standard 12-lead ECGs
• Subjects need to be supine and at rest for ≥ 10minutes prior to the ECG

Vitals

Screening

Day 1: Pre-dose, 3, 5, 8 and 24 hr

Day 8: Pre-dose, 3, 5, 8 and 24 hr

• Orthostatic (supine, sitting and standing) bloodpressure and heart rate, body temperature andrespiration rate. Orthostatic assessments are tobe made after subjects have been in the supineposition for at least 5 minutes and again aftersubjects have been standing for 2 minutes.
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