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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Nalmefene 18 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01934166

15084A

2012-005711-53 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

32 participants in 1 patient group

Nalmefene 18 mg

Experimental group

Description:

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Treatment:

Drug: Nalmefene 18 mg