A Water Consumption Study of ALKS 5461 in Healthy Volunteers | NCT02521857

Studies
A Water Consumption Study of ALKS 5461 in Healthy Volunteers

NCT02521857

Sponsor

Alkermes, Inc.

Status

Completed

Last Update Posted

Nov 10, 2015Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ALKS 5461

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Aug 11, 2015

First Submission Date that Met QC Criteria

Aug 11, 2015

First Posted Date

Aug 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2015

Last Update Posted Date

Nov 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALKS 5461	Experimental	Sublingual tablet	Drug: ALKS 5461

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALKS 5461	Drug	Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints	ALKS 5461

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided