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

A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461

This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: 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: 18 years to 50 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/m^2
• 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:

• Is currently pregnant or breastfeeding
• Has a lifetime history of substance abuse disorder
• Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
• Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception or prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
• Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
• Has used alcohol within 72 hours prior to any inpatient period
• Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
• Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
• Additional criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALKS 5461; Sublingual tablet	Drug: ALKS 5461; Sublingual tablet given alone and in conjunction with Rifampin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin	Up to 72 hours
AUClast	Area under the concentration time curve from time 0 to the last measurable timepoint in the presence and absence of rifampin	Up to 72 hours
Cmax	Maximum plasma concentration in the presence and absence of rifampin.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability will be measured by the incidence of Adverse Events	UP to 27 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Pharmacokinetics; Alkermes; Samidorphan; ALKS 5461
• Other Study ID Numbers: ALK5461-A109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No