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

A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Itraconazole; Drug: ALKS 5461

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Itraconazole; Itraconazole or placebo	Drug: Itraconazole; Administered orally in a crossover design; Other Names: Itraconazole or placebo
Experimental: ALKS 5461; ALKS 5461 or placebo Sublingual tablet	Drug: ALKS 5461; Administered sublingually in a crossover design; Other Names: ALKS 5461 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 48 hours
Drug-Drug Interaction - Cmax	Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole	Up to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability will be measured by incidence of adverse events	Up to 32 Days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Hydroxyitraconazole
• Other Study ID Numbers: ALK5461-214