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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Nalmefene 18 mg

• Registration Number: NCT01934166
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2014-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nalmefene 18 mg	Nalmefene 18 mg	18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Primary Outcome Measures

Name	Time	Method
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: 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 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 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: apparent volume of distribution for nalmefene (Vz /F)	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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Up to 10 days	Number of adverse events

Trial Locations

Locations (1)

DE801; 🇩🇪 Munich, Germany