Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients (RELZH12)

University of Zurich (UZH)

Status and phase

Completed

Phase 1

Conditions

Opioid Use, Unspecified With Other Opioid-induced Disorder

Treatments

Drug: Methylnaltrexone

Study type

Interventional

Funder types

Other

Identifiers

NCT01889290

RELZH12

Details and patient eligibility

About

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

Full description

After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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