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

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Lundbeck

Status and phase

Completed
Phase 1

Conditions

Renal Impairment

Treatments

Drug: Nalmefene 18 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01934166
15084A
2012-005711-53 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

32 participants in 1 patient group

Nalmefene 18 mg
Experimental group
Description:
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Treatment:
Drug: Nalmefene 18 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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