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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934166
• Other study ID #: 15084A
• Secondary ID: 2012-005711-53
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2013
• Last updated: November 7, 2016
• Start date: July 2013

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Nalmefene 18 mg
One single oral dose of 18 mg

Locations

Country	Name	City	State
Germany	DE801	Munich

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)		Up to 120 hours post-dose	No
Primary	For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)		Up to 120 hours post-dose	No
Primary	For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)		Up to 120 hours post-dose	No
Primary	For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)		Up to 120 hours post-dose	No
Primary	For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)		Up to 120 hours post-dose	No
Primary	For nalmefene: apparent volume of distribution for nalmefene (Vz /F)		Up to 120 hours post-dose	No
Primary	For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent		Up to 120 hours post-dose	No
Secondary	Safety and tolerability	Number of adverse events	Up to 10 days	Yes