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
1 other identifier
interventional
24
1 country
1
Brief Summary
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 12, 2014
December 1, 2014
1 month
October 17, 2014
December 11, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Drug-Drug Interaction - Cmax
Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
Up to 48 hours
Secondary Outcomes (1)
Safety and tolerability will be measured by incidence of adverse events
Up to 32 Days
Study Arms (2)
Itraconazole
OTHERItraconazole or placebo
ALKS 5461
EXPERIMENTALALKS 5461 or placebo Sublingual tablet
Interventions
Administered orally in a crossover design
Administered sublingually in a crossover design
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
Alkermes Investigational Site
Overland Park, Kansas, 66212, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sanjeev Pathak, MD
Alkermes, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 23, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 12, 2014
Record last verified: 2014-12