Paracetamol CSF Pharmacokinetics Study

NCT01821872 | Completed Phase 4 DMC

• 1 other identifier: 7258
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite its use for decades all over the world, the exact mechanism of action of paracetamol is not fully understood and essentially involves a combination of hypotheses. It is known to have an effect via the central nervous system, and of the many mechanisms proposed, one hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its novel metabolite AM404. This study aims to elucidate cerebrospinal levels of paracetamol and to measure the concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful information on the mechanism of action of paracetamol.

Conditions

Paracetamol

Keywords

paracetamol; acetaminophen; AM404; CSF; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Measurement of AM404 in CSF

  AM404 is a metabolite of paracetamol thought to be formed in the brain.

  5-211 minutes post-administration of paracetamol

Secondary Outcomes (2)

• Measurement of paracetamol in plasma and CSF

  5-211 minutes post administration of paracetamol

• Measurement of paracetamol glucuronide and sulphate conjugates in plasma and CSF.

  5-211 minutes post administration of paracetamol

Study Arms (3)

Sampling at approx 15 minutes

ACTIVE COMPARATOR

Plasma and CSF samples to be taken at 15 minutes post administration of intravenous paracetamol

Drug: Administration of paracetamol

Sampling at approx 30 minutes

ACTIVE COMPARATOR

Plasma and CSF samples to be taken at 30 minutes post administration of intravenous paracetamol

Drug: Administration of paracetamol

Sampling at approx 120minutes

ACTIVE COMPARATOR

Plasma and CSF samples to be taken at 120 minutes post administration of intravenous paracetamol

Drug: Administration of paracetamol

Interventions

Administration of paracetamol DRUG

Administration of 1g intravenous paracetamol

Also known as: Perfalgan

Sampling at approx 120minutes; Sampling at approx 15 minutes; Sampling at approx 30 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects aged 18 to 80 years
• Subjects undergoing surgery who require a spinal anaesthetic and paracetamol as part of their routine anaesthetic plan
• Subjects with an American Society of Anesthesiology score of I-III

You may not qualify if:

• Subjects with any contraindication to spinal anaesthesia
• Subjects with known clotting abnormalities
• Pregnant or lactating women
• Subjects with known hypersensitivity to paracetamol
• Patients with severe hepatocellular insufficiency
• Patients already taking regular doses of paracetamol
• Any subjects deemed medically unsuitable by the investigator

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

St Bartholomew's Hospital

London, EC1A, United Kingdom

Location

Study Officials

• Vivek Mehta, MD

  Pain and Anaesthesia Research Centre, Barts Health NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

GB (1)