A Study of ALKS 5461 in Healthy Volunteers | NCT02068105

Studies
A Study of ALKS 5461 in Healthy Volunteers

NCT02068105

Sponsor

Alkermes, Inc.

Status

Completed

Last Update Posted

Apr 21, 2014Estimated

Enrollment

104Actual

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

ALKS 5461
Placebo

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

Apr 2014

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

Jan 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 12, 2014

First Submission Date that Met QC Criteria

Feb 19, 2014

First Posted Date

Feb 21, 2014Estimated

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

Apr 18, 2014

Last Update Posted Date

Apr 21, 2014Estimated

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

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ALKS 5461-A	Experimental	Drug: ALKS 5461
ALKS 5461-B	Experimental	Drug: ALKS 5461
ALKS 5461 Dose 1	Experimental	Drug: ALKS 5461
ALKS 5461 Dose 2	Experimental	Drug: ALKS 5461
ALKS 5461 Dose 3	Experimental	Drug: ALKS 5461
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALKS 5461	Drug	Sublingual tablet	ALKS 5461 Dose 1 ALKS 5461 Dose 2 ALKS 5461 Dose 3 ALKS 5461-A ALKS 5461-B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative bioavailability of ALKS 5461 treatment groups	The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).	21 days

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability: Incidence of adverse events		21 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be in good physical health
Body mass index of 18-30 kg/m2
Agree to use an approved method of birth control for the duration of the study
Additional criteria may apply

Exclusion Criteria:

Currently pregnant or breastfeeding
History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
Current or history of any clinically significant medical or psychiatric condition
Current abuse or dependence on alcohol or any illicit drugs
Have used nicotine within 90 days
Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, 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