Clinical trial NCT02804568: A Phase 1 Safety Study in Adults With Schizophrenia
Official title: A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Alkermes
ALK 3831
Samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of 18.0-35.0 kg/m\^2, inclusive
* Has a primary diagnosis of schizophrenia
* Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
* Appropriate for outpatient treatment
* Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
* Willing and able to provide government-issued identification
* Is in good physical health
* Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
* Poses a current suicide risk at Visits 1 or 2
* Has a history of poor or inadequate response to treatment with olanzapine
* Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
* Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
* Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
* Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
* Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
* Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
* Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
* Additional criteria may apply

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 15 days of dosing
measure: Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)
timeFrame: Up to 15 days of dosing
Secondary outcomes:
measure: Safety will be determined by incidence of drug-related adverse events
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Clementon
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References:
citation: Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.