- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934166
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
November 7, 2016 updated by: H. Lundbeck A/S
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
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany, 81241
- DE801
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nalmefene 18 mg
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
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One single oral dose of 18 mg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Up to 120 hours post-dose
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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
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Up to 120 hours post-dose
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For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)
Time Frame: Up to 120 hours post-dose
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Up to 120 hours post-dose
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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
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Up to 120 hours post-dose
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For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)
Time Frame: Up to 120 hours post-dose
|
Up to 120 hours post-dose
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For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)
Time Frame: Up to 120 hours post-dose
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Up to 120 hours post-dose
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For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)
Time Frame: Up to 120 hours post-dose
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Up to 120 hours post-dose
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For nalmefene: apparent volume of distribution for nalmefene (Vz /F)
Time Frame: Up to 120 hours post-dose
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Up to 120 hours post-dose
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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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Up to 120 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: Up to 10 days
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Number of adverse events
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Up to 10 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Estimate)
November 8, 2016
Last Update Submitted That Met QC Criteria
November 7, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15084A
- 2012-005711-53 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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