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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: ALKS 5461; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02272764

ALK5461-214

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Itraconazole

Other group

Description:

Itraconazole or placebo

Treatment:

Drug: Itraconazole

ALKS 5461

Experimental group

Description:

ALKS 5461 or placebo Sublingual tablet

Treatment:

Drug: ALKS 5461