A Phase 1 Safety Study in Adults With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804568
• Other study ID #: ALK3831-A104
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2016
• Last updated: September 21, 2016
• Start date: June 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ALKS 3831
Oral capsule, daily administration

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Clementon	New Jersey
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		Up to 15 days of dosing	No
Primary	Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)		Up to 15 days of dosing	No
Secondary	Safety will be determined by incidence of drug-related adverse events		Up to 21 days	Yes