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Completed

NCT Number: NCT02508506

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational SIte, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 5461

Drug

Single dose, given orally

Primary outcomes

  1. 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

  2. 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

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

    Time frame: up to 168 hours postdose

Secondary outcomes

  1. Time to reach maximum plasma concentration (TMAX)

    Time frame: up to 168 hours postdose

  2. Terminal elimination half-life (T1/2)

    Time frame: up to 168 hours postdose

  3. Apparent clearance (CL/F)

    Time frame: up to 168 hours postdose

  4. Apparent volume of distribution (Vz/F)

    Time frame: up to 168 hours postdose

  5. Safety: Incidence of adverse events (SAE)

    Time frame: Up to 12 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2015
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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