Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene

Official Title
-----------------
An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: Nalmefene 18 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-<50 ml/min/1.73m2, <30 ml/min/1.73m2 will be included in the study. The subjects must have a BMI between 19 and 32 kg/m2. Exclusion Criteria: The subject has a history of renal transplant or is undergoing dialyse treatment. The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalmefene 18 mg<br>18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride | Drug: Nalmefene 18 mg<br>* One single oral dose of 18 mg<br>* Other names: Selincro®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf) |  | Up to 120 hours post-dose | 
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t) |  | Up to 120 hours post-dose | 
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax) |  | Up to 120 hours post-dose | 
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax) |  | Up to 120 hours post-dose | 
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½) |  | Up to 120 hours post-dose | 
| For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR) |  | Up to 120 hours post-dose | 
| For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F) |  | Up to 120 hours post-dose | 
| For nalmefene: apparent volume of distribution for nalmefene (Vz /F) |  | Up to 120 hours post-dose | 
| For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent |  | Up to 120 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Number of adverse events | Up to 10 days |