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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01934166

Enrollment

Registered

2013-09-04

Start date

2013-07-31

Completion date

Unknown

Last updated

2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Brief summary

To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene

Interventions

DRUGNalmefene 18 mg

One single oral dose of 18 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent	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 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

Secondary

Measure	Time frame	Description
Safety and tolerability	Up to 10 days	Number of adverse events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026