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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Nalmefene; Naltrexone

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.