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

NCT01934166 | Completed Phase 1

• 2 other identifiers: 15084A2012-005711-53
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (9)

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

  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)

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

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

  Up to 120 hours post-dose

Secondary Outcomes (1)

• Safety and tolerability

  Up to 10 days

Study Arms (1)

Nalmefene 18 mg

EXPERIMENTAL

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Drug: Nalmefene 18 mg

Interventions

Nalmefene 18 mg DRUG

One single oral dose of 18 mg

Also known as: Selincro®

Nalmefene 18 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

DE801

Munich, 81241, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 4, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

DE (1)