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

NCT02545439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-10

No results posted yet for this study

Summary

This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ALKS 5461

Sublingual tablet given alone and in conjunction with Rifampin

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Arielle Stanford, MD · Alkermes, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545439 on ClinicalTrials.gov