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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02272764

Enrollment

Registered

2014-10-23

Start date

2014-10-31

Completion date

2014-11-30

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Brief summary

This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Interventions

DRUGItraconazole

Administered orally in a crossover design

DRUGALKS 5461

Administered sublingually in a crossover design

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Drug-Drug Interaction - AUC0-t	Up to 48 hours	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
Drug-Drug Interaction - AUC0-inf	Up to 48 hours	Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - Cmax	Up to 48 hours	Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole

Secondary

Measure	Time frame
Safety and tolerability will be measured by incidence of adverse events	Up to 32 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026