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.

June 26, 2014 updated by: Mundipharma Research Limited

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
        • Quotient Clinical Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 12 hourly capsule fasted
4 mg 12 hourly capsule - strong pain killer fasted
Drug: 4 mg 12 hourly capsule - strong pain killer fed
Other Names:
  • MR2XXX
Active Comparator: 12 hourly capsule fed
4 mg 12 hourly capsule - strong pain killer fed
Drug: 4 mg 12 hourly capsule - strong pain killer fasted
Other Names:
  • MR2XXX
Experimental: 12 hourly capsule with antagonist fasted
4 mg 12 hourly capsule strong painkiller with antagonist fasted
Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed
Other Names:
  • MR2XXX
Experimental: 12 hourly capsule with antagonist fed
4 mg 12 hourly capsule strong painkiller with antagonist fed
Drug: 12 hourly capsule strong painkiller with antagonist fasted)
Other Names:
  • MR2XXX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics parameters AUC and Cmax
Time Frame: Up to 32 hours
Up to 32 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 7 to 10 days
AEs will be recorded through spontaneous reporting
7 to 10 days
Vital Signs
Time Frame: 0 to 32 hours
Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate
0 to 32 hours
Clinical Laboratory Tests
Time Frame: 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
Day 0 and Day 7-10
ECG
Time Frame: Screening, 1 our post-dose and Day 7-10
ECGs
Screening, 1 our post-dose and Day 7-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Research Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMX1507
  • 2013-005522-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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