NCT02133820

A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.

A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

Detailed description

This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	4 mg 12 hourly capsule - strong pain killer fasted
DRUG	4 mg 12 hourly capsule - strong pain killer fed
DRUG	12 hourly capsule strong painkiller with antagonist fasted)
DRUG	4 mg 12 hourly capsule strong painkiller with antagonist fed

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-08
• Last updated: 2014-06-27

Locations

1 site across 1 country: United Kingdom