A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALKS 5461

Sublingual tablet

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints

Interventions

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ALKS 5461

Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes