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

NCT ID: NCT01934166

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Nalmefene 18 mg

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Group Type EXPERIMENTAL

Nalmefene 18 mg

Intervention Type DRUG

One single oral dose of 18 mg

Interventions

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Nalmefene 18 mg

One single oral dose of 18 mg

Intervention Type DRUG

Other Intervention Names

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Selincro®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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DE801

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-005711-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15084A

Identifier Type: -

Identifier Source: org_study_id