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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Itraconazole; Drug: ALKS 5461

• Registration Number: NCT02272764
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole	Itraconazole or placebo
ALKS 5461	ALKS 5461	ALKS 5461 or placebo Sublingual tablet

Primary Outcome Measures

Name	Time	Method
Drug-Drug Interaction - AUC0-t	Up to 48 hours	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
Drug-Drug Interaction - AUC0-inf	Up to 48 hours	Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - Cmax	Up to 48 hours	Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be measured by incidence of adverse events	Up to 32 Days

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States