Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006361

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006361
  •   2014/09/03
  •   2013/08/22
  •   no
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Secondary IDs

  •   NCT01934166  (ClinicalTrials.gov)
  •   15084A  (H. Lundbeck A/S)
  •   2012-005711-53 
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Health Condition or Problem studied

  •   Renal Impairment
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: Nalmefene 18 mg
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   Single (group)
  •   IV
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Primary Outcome

- 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
- 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
- For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax); time frame: Up to 120 hours post-dose
- 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
- For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½); time frame: Up to 120 hours post-dose
- For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR); time frame: Up to 120 hours post-dose
- For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F); time frame: Up to 120 hours post-dose
- For nalmefene: apparent volume of distribution for nalmefene (Vz /F); time frame: Up to 120 hours post-dose
- 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

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Secondary Outcome

- Safety and tolerability; time frame: Up to 10 days; Number of adverse events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/07/31
  •   32
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional 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.

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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.

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Addresses

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    • H. Lundbeck A/S
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    • LundbeckClinicalTrials@lundbeck.com
    • Email contact via H. Lundbeck A/S 
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    • LundbeckClinicalTrials@lundbeck.com
    • Email contact via H. Lundbeck A/S 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.