A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545439
• Other study ID #: ALK5461-A109
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2015
• Last updated: November 9, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• 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 study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 lifetime 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 or 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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ALKS 5461
Sublingual tablet given alone and in conjunction with Rifampin

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	AUCinf	Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin	Up to 72 hours	No
Primary	AUClast	Area under the concentration time curve from time 0 to the last measurable timepoint in the presence and absence of rifampin	Up to 72 hours	No
Primary	Cmax	Maximum plasma concentration in the presence and absence of rifampin.	Up to 72 hours	No
Secondary	Safety and tolerability will be measured by the incidence of Adverse Events		UP to 27 days	Yes