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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Pain

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 12 hourly capsule fasted<br>4 mg 12 hourly capsule - strong pain killer fasted | Drug: 4 mg 12 hourly capsule - strong pain killer fed<br> <br> * Other names: MR2XXX;|
| Active Comparator: 12 hourly capsule fed<br>4 mg 12 hourly capsule - strong pain killer fed | Drug: 4 mg 12 hourly capsule - strong pain killer fasted<br> <br> * Other names: MR2XXX;|
| Experimental: 12 hourly capsule with antagonist fasted<br>4 mg 12 hourly capsule strong painkiller with antagonist fasted | Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed<br> <br> * Other names: MR2XXX;|
| Experimental: 12 hourly capsule with antagonist fed<br>4 mg 12 hourly capsule strong painkiller with antagonist fed | Drug: 12 hourly capsule strong painkiller with antagonist fasted)<br> <br> * Other names: MR2XXX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters AUC and Cmax |  | Up to 32 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, Pharmacokinetics