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

NCT02508506 | Completed Phase 1

• 1 other identifier: ALKS5461-A108
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Renal Impairment

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  up to 168 hours postdose

• 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

  up to 168 hours postdose

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

  up to 168 hours postdose

Secondary Outcomes (5)

• Time to reach maximum plasma concentration (TMAX)

  up to 168 hours postdose

• Terminal elimination half-life (T1/2)

  up to 168 hours postdose

• Apparent clearance (CL/F)

  up to 168 hours postdose

• Apparent volume of distribution (Vz/F)

  up to 168 hours postdose

• Safety: Incidence of adverse events (SAE)

  Up to 12 days

Study Arms (1)

ALKS 5461

EXPERIMENTAL

Sublingual tablet

Drug: ALKS 5461

Interventions

ALKS 5461 DRUG

Single dose, given orally

ALKS 5461

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (3)

Alkermes Investigational SIte

Denver, Colorado, 80228, United States

Location

Alkermes Investigational SIte

Orlando, Florida, 32809, United States

Location

Alkermes Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Arielle Stanford, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

US (3)