A Water Consumption Study of ALKS 5461 in Healthy Volunteers

A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ALKS 5461

• Study Type: Interventional
• Enrollment (Actual): 30
• 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: Yes
• 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 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 of 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALKS 5461; Sublingual tablet	Drug: ALKS 5461; Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461	Up to 72 hours
AUClast	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461	Up to 72 hours
Cmax	Maximum observed plasma concentration for ALKS 5461	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability will be measured by the incidence of Adverse Effects	Up to 46 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 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-A110