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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ALKS 5461

• Registration Number: NCT02545439
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 5461	ALKS 5461	Sublingual tablet

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be measured by the incidence of Adverse Events	UP to 27 days

Trial Locations

Locations (1)

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