A Phase 1 Safety Study in Adults With Schizophrenia

Alkermes

Status and phase

Completed

Phase 1

Conditions

Schizophrenia

Treatments

Drug: ALKS 3831

Study type

Interventional

Funder types

Industry

Identifiers

NCT02804568

ALK3831-A104

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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