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

NCT02545439 | Completed Phase 1

• 1 other identifier: ALK5461-A109
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Alkermes; Samidorphan; ALKS 5461; Healthy Volunteer; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety and tolerability will be measured by the incidence of Adverse Events

  UP to 27 days

Study Arms (1)

ALKS 5461

EXPERIMENTAL

Sublingual tablet

Drug: ALKS 5461

Interventions

ALKS 5461 DRUG

Sublingual tablet given alone and in conjunction with Rifampin

ALKS 5461

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

ALKS 5461

Study Officials

• Arielle Stanford, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

US (1)