Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Methylnaltrexone; Naltrexone; Sufentanil

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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