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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508506
• Other study ID #: ALKS5461-A108
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2015
• Last updated: February 3, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• ALKS 5461
Single dose, given orally

Locations

Country	Name	City	State
United States	Alkermes Investigational SIte	Denver	Colorado
United States	Alkermes Investigational Site	Minneapolis	Minnesota
United States	Alkermes Investigational SIte	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461		up to 168 hours postdose	No
Secondary	Time to reach maximum plasma concentration (TMAX)		up to 168 hours postdose	No
Secondary	Terminal elimination half-life (T1/2)		up to 168 hours postdose	No
Secondary	Apparent clearance (CL/F)		up to 168 hours postdose	No
Secondary	Apparent volume of distribution (Vz/F)		up to 168 hours postdose	No
Secondary	Safety: Incidence of adverse events (SAE)		Up to 12 days	Yes