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

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

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

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: ALKS 5461


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 5461<br>Sublingual tablet | Drug: ALKS 5461<br>* Single dose, given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Samidorphan, ALKS 5461, Alkermes, Renal Impairment, Pharmacokinetics, Buprenorphine