Skip to main content
OpenTrials
Completed

NCT Number: 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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Limited

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4 mg 12 hourly capsule - strong pain killer fasted

Drug

Other names: MR2XXX

4 mg 12 hourly capsule - strong pain killer fed

Drug

Other names: MR2XXX

12 hourly capsule strong painkiller with antagonist fasted)

Drug

Other names: MR2XXX

4 mg 12 hourly capsule strong painkiller with antagonist fed

Drug

Other names: MR2XXX

Primary outcomes

  1. Pharmacokinetics parameters AUC and Cmax

    Time frame: Up to 32 hours

Secondary outcomes

  1. Adverse Events

    Time frame: 7 to 10 days

    AEs will be recorded through spontaneous reporting

  2. Vital Signs

    Time frame: 0 to 32 hours

    Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate

  3. 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

  4. ECG

    Time frame: Screening, 1 our post-dose and Day 7-10

    ECGs

Sponsors and collaborators

Lead sponsor

Mundipharma Research Limited

Industry

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 8, 2014
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.