Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

Phase 1

Completed

• Conditions: Opioid Use, Unspecified With Other Opioid-induced Disorder
• Interventions: Drug: Methylnaltrexone

• Registration Number: NCT01889290
• Lead Sponsor: University of Zurich

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

Detailed 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.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-28
• Study Start: 2014-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methylnaltrexone	Methylnaltrexone	Pharmacokinetics of methylnaltrexone administered once daily

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)	5 days

Trial Locations

Locations (1)

Neurointensive Care Unit; 🇨🇭 Zurich, Switzerland