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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALKS 5461

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring ALKS 5461, Alkermes, Samidorphan, Renal Impairment, Pharmacokinetics, Buprenorphine

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For all subjects:

Has a body mass index (BMI) of 18.0-40.0 kg/m^2 and a total body weight >50kg
Agrees to use an approved method of contraception for the duration of the study
Additional criteria may apply

For subjects with renal impairment:

Has severe or end stage renal disease, and does not require dialysis
Has stable renal function for at least 60 days preceding screening
Additional criteria may apply

Exclusion Criteria:

For all subjects:

Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment
Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy
Is pregnant, planning to become pregnant, or lactating
Has a history of clinically significant allergy or a hypersensitivity to opioids
Additional criteria my apply

For subjects with renal impairment:

Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
Has received a kidney transplant
Additional criteria may apply

Sites / Locations

Alkermes Investigational SIte
Alkermes Investigational SIte
Alkermes Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALKS 5461

Arm Description

Sublingual tablet

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461

Area under the plasma concentration versus time curve from time 0 to time of last measurable concentration (AUC0-last) following a single dose of ALKS 5461

Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461

Secondary Outcome Measures

Time to reach maximum plasma concentration (TMAX)

Terminal elimination half-life (T1/2)

Apparent clearance (CL/F)

Apparent volume of distribution (Vz/F)

Safety: Incidence of adverse events (SAE)

Full Information

NCT ID

NCT02508506

First Posted

July 23, 2015

Last Updated

February 3, 2016

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02508506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

ALKS 5461, Alkermes, Samidorphan, Renal Impairment, Pharmacokinetics, Buprenorphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALKS 5461

Arm Type

Experimental

Arm Description

Sublingual tablet

Intervention Type

Drug

Intervention Name(s)

ALKS 5461

Intervention Description

Single dose, given orally

Primary Outcome Measure Information:

Title

Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461

Time Frame

up to 168 hours postdose

Title

Area under the plasma concentration versus time curve from time 0 to time of last measurable concentration (AUC0-last) following a single dose of ALKS 5461

Time Frame

up to 168 hours postdose

Title

Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461

Time Frame

up to 168 hours postdose

Secondary Outcome Measure Information:

Title

Time to reach maximum plasma concentration (TMAX)

Time Frame

up to 168 hours postdose

Title

Terminal elimination half-life (T1/2)

Time Frame

up to 168 hours postdose

Title

Apparent clearance (CL/F)

Time Frame

up to 168 hours postdose

Title

Apparent volume of distribution (Vz/F)

Time Frame

up to 168 hours postdose

Title

Safety: Incidence of adverse events (SAE)

Time Frame

Up to 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For all subjects: Has a body mass index (BMI) of 18.0-40.0 kg/m^2 and a total body weight >50kg Agrees to use an approved method of contraception for the duration of the study Additional criteria may apply For subjects with renal impairment: Has severe or end stage renal disease, and does not require dialysis Has stable renal function for at least 60 days preceding screening Additional criteria may apply Exclusion Criteria: For all subjects: Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy Is pregnant, planning to become pregnant, or lactating Has a history of clinically significant allergy or a hypersensitivity to opioids Additional criteria my apply For subjects with renal impairment: Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis Has received a kidney transplant Additional criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arielle Stanford, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Alkermes Investigational SIte

City

Denver

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Alkermes Investigational SIte

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Alkermes Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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