Clinical trial NCT02508506: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: ALKS 5461
Alkermes
Samidorphan
Renal Impairment
Pharmacokinetics
Buprenorphine
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
timeFrame: up to 168 hours postdose
measure: 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
timeFrame: up to 168 hours postdose
measure: Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
timeFrame: up to 168 hours postdose
Secondary outcomes:
measure: Time to reach maximum plasma concentration (TMAX)
timeFrame: up to 168 hours postdose
measure: Terminal elimination half-life (T1/2)
timeFrame: up to 168 hours postdose
measure: Apparent clearance (CL/F)
timeFrame: up to 168 hours postdose
measure: Apparent volume of distribution (Vz/F)
timeFrame: up to 168 hours postdose
measure: Safety: Incidence of adverse events (SAE)
timeFrame: Up to 12 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Alkermes Investigational SIte
state: Colorado
city: Orlando
country: United States
facility: Alkermes Investigational SIte
state: Florida
city: Minneapolis
country: United States
facility: Alkermes Investigational Site
state: Minnesota
Study officials:
affiliation: Alkermes, Inc.
name: Arielle Stanford, MD
role: STUDY_DIRECTOR
References: