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

Pharmacokinetics Clinical Trial

Official title:

A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272764
• Other study ID #: ALK5461-214
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2014
• Last updated: December 11, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: December 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 study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• 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/m2

• 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:

• Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality

• Is currently pregnant or breastfeeding

• Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)

• Has a lifetime history of opioid abuse or dependence

• Has current abuse or dependence on alcohol or any drugs

• Has used nicotine within 90 days prior to randomization

• 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:
• Itraconazole
Administered orally in a crossover design
• ALKS 5461
Administered sublingually in a crossover design

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	Drug-Drug Interaction - AUC0-t	Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole	Up to 48 hours	No
Primary	Drug-Drug Interaction - AUC0-inf	Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole	Up to 48 hours	No
Primary	Drug-Drug Interaction - Cmax	Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole	Up to 48 hours	No
Secondary	Safety and tolerability will be measured by incidence of adverse events		Up to 32 Days	Yes