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.

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: 4 mg 12 hourly capsule - strong pain killer fed; Drug: 4 mg 12 hourly capsule - strong pain killer fasted; Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed; Drug: 12 hourly capsule strong painkiller with antagonist fasted)

• Registration Number: NCT02133820
• Lead Sponsor: Mundipharma Research Limited

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-25
• Study Start: 2014-04
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
12 hourly capsule fasted	4 mg 12 hourly capsule - strong pain killer fed	4 mg 12 hourly capsule - strong pain killer fasted
12 hourly capsule fed	4 mg 12 hourly capsule - strong pain killer fasted	4 mg 12 hourly capsule - strong pain killer fed
12 hourly capsule with antagonist fasted	4 mg 12 hourly capsule strong painkiller with antagonist fed	4 mg 12 hourly capsule strong painkiller with antagonist fasted
12 hourly capsule with antagonist fed	12 hourly capsule strong painkiller with antagonist fasted)	4 mg 12 hourly capsule strong painkiller with antagonist fed

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters AUC and Cmax	Up to 32 hours

Secondary Outcome Measures

Name	Time	Method
Adverse Events	7 to 10 days	AEs will be recorded through spontaneous reporting
Vital Signs	0 to 32 hours	Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate
Clinical Laboratory Tests	Day 0 and Day 7-10	Clinical laboratory tests - blood samples will be taken at screening and post-study medical for routine laboratory analysis (haematology, blood chemistry and urinalysis
ECG	Screening, 1 our post-dose and Day 7-10	ECGs

Trial Locations

Locations (1)

Quotient Clinical Limited; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom