A Study of ALKS 5461 in Healthy Volunteers

Pharmacokinetics Clinical Trial

Official title:

A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068105
• Other study ID #: ALK5461-209
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2014
• Last updated: April 18, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to test the safety of ALKS 5461 in healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• ALKS 5461
Sublingual tablet
• Placebo
Sublingual tablet

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability of ALKS 5461 treatment groups	The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).	21 days	No
Secondary	Safety and tolerability: Incidence of adverse events		21 days	No