Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

NCT01889290 | Completed Phase 1 DMC

• 1 other identifier: RELZH12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

• Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
• Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
• Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
• Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
• Trial with medicinal product

Conditions

Opioid Use, Unspecified With Other Opioid-induced Disorder

Keywords

methylnaltrexone; opioid-antagonist; Obstipation; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)

  5 days

Study Arms (1)

Methylnaltrexone

EXPERIMENTAL

Pharmacokinetics of methylnaltrexone administered once daily

Drug: Methylnaltrexone

Interventions

Methylnaltrexone DRUG

Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl

Also known as: Relistor

Methylnaltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalisation in the neurointensive care unit
• deep sedation with sufentanil doses of = 40 mcg/h
• male or female aged 18 years or older
• females: negative pregnancy test
• Ventricular drainage as part of needed therapeutic measures

You may not qualify if:

• History of hypersensitivity to methylnaltrexone (Relistor®)
• confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
• increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
• severe hepatic insufficiency (Child-Pugh Class C)
• renal impairment (glomerular filtration rate \< 90 ml/min) with or without renal replacement therapy
• severe diarrhea despite high opioid dosing
• participation in another study with an investigational drug within the 30 days preceding and during the present study

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Neurointensive Care Unit

Zurich, Switzerland

Location

MeSH Terms

Interventions

methylnaltrexone

Study Officials

• Natascia Corti, MD

  University Hospital Zurich, Pharmacology and Toxicology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 28, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

CH (1)