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Completed

NCT Number: NCT01934166

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DE801

Munich, 81241, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nalmefene 18 mg

Drug

One single oral dose of 18 mg

Other names: Selincro®

Primary outcomes

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

    Time frame: Up to 120 hours post-dose

  2. 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)

    Time frame: Up to 120 hours post-dose

  3. For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)

    Time frame: Up to 120 hours post-dose

  4. For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)

    Time frame: Up to 120 hours post-dose

  5. For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)

    Time frame: Up to 120 hours post-dose

  6. For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)

    Time frame: Up to 120 hours post-dose

  7. For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)

    Time frame: Up to 120 hours post-dose

  8. For nalmefene: apparent volume of distribution for nalmefene (Vz /F)

    Time frame: Up to 120 hours post-dose

  9. For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent

    Time frame: Up to 120 hours post-dose

Secondary outcomes

  1. Safety and tolerability

    Time frame: Up to 10 days

    Number of adverse events

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
First posted
Sep 4, 2013
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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