Summary:
Alkermes A104 (Inpatient)
This is a Phase 1, multi-center, open-label, randomized study in approximately
42 subjects (minimum 14 females) with schizophrenia. Subjects will be screened up to 21 days prior to
enrolling into a qualifying 1-week lead-in of 15 mg/day olanzapine treatment. The study duration is
approximately 7 weeks; up to three weeks of screening, one week of outpatient olanzapine lead-in
(Days -8 to -2) and one 15-day inpatient stay (Days -1 to 15) with safety follow-up visit on Day 21.
Screening assessments will occur in the 21-day period before subjects report to the study center for
verification of eligibility and initiation of olanzapine treatment (Day -8). On Day -7 all eligible subjects
will be initiated on olanzapine. Olanzapine dose will be selected and titrated (up to 15 mg/day) by the
principal investigator based upon individual subject needs and consistent with current clinical practice.
By 5 days into the olanzapine lead-in (Day -3) subjects must be on a 15 mg/day. On Day -1 subjects
will take their last dose of olanzapine lead-in and will return to the study center for a 15-night inpatient
stay and the start of the 2-week PK study.
At Day 1 approximately 42 subjects will be randomized (1:1)
into two treatment groups and administered a fixed-dose combination of olanzapine and samidorphan:
- Group 1: ALKS 3831 10/10 (olanzapine/samidorphan 10 mg/10 mg)
- Group 2: ALKS 3831 20/10 (olanzapine/samidorphan 20 mg/10 mg)
Subjects will receive the same oral dose of ALKS 3831 10/10 or ALKS 3831 20/10 once daily for 14
consecutive days (Day 1 to Day 14) to reach steady state exposure. Subjects will be discharged on Day
15, approximately 24 hours after the last dose administration on Day 14, once all inpatient PK and
safety assessments are completed. A safety follow-up visit will be conducted on Day 21.
Qualified Participants Must:
• Be between 18 to 65 years of age
• Have a BMI of 18.0-25.0 kg/m2
• Be willing to provide government issued identification
• Maintain your normal tobacco use throughout the study
Qualified Participants May Receive:
Monetary compensation for the pre-screening process in the form of a $25 Wal-Mart gift card and if the qualifying participant signs informed consent they will be paid on the Clincard for the visit.