A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

Phase 1CompletedNCT02272764

Alkermes, Inc.24 enrolled

Overview

This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pharmacokinetics

Interventions

ItraconazoleDRUG

Administered orally in a crossover design

ALKS 5461DRUG

Administered sublingually in a crossover design

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Has a body mass index (BMI) of 18.0 - 30.0 kg/m2 * Is in good physical health * Agrees to use an approved method of contraception for the duration of the study * Additional criteria may apply Exclusion Criteria: * Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality * Is currently pregnant or breastfeeding * Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) * Has a lifetime history of opioid abuse or dependence * Has current abuse or dependence on alcohol or any drugs * Has used nicotine within 90 days prior to randomization * Additional criteria may apply

Locations (1)

Alkermes Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Drug-Drug Interaction - AUC0-t

Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole

Time frame: Up to 48 hours

Drug-Drug Interaction - AUC0-inf

Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole

Time frame: Up to 48 hours

Drug-Drug Interaction - Cmax

Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole

Time frame: Up to 48 hours

Secondary Outcomes

Safety and tolerability will be measured by incidence of adverse events

Time frame: Up to 32 Days

Data from ClinicalTrials.gov

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