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Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

ClinicalTrials.gov ID: NCT02508506

Public ClinicalTrials.gov record NCT02508506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS5461 in Subjects With Renal Impairment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.

Study identification

NCT ID
NCT02508506
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
22 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 79 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2015
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015
Last update posted
Feb 3, 2016

2015

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Alkermes Investigational SIte Denver Colorado 80228
Alkermes Investigational SIte Orlando Florida 32809
Alkermes Investigational Site Minneapolis Minnesota 55404

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02508506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 3, 2016 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02508506 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →