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

Phase 1CompletedNCT01934166

H. Lundbeck A/S32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

Nalmefene 18 mgDRUG

One single oral dose of 18 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

DE801

Munich, Germany

Outcomes

Primary Outcomes

For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)