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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133820

Enrollment

Registered

2014-05-08

Start date

2014-04-30

Completion date

2014-06-30

Last updated

2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Healthy Volunteer, Pharmacokinetics

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.

Interventions

DRUG4 mg 12 hourly capsule - strong pain killer fasted

DRUG4 mg 12 hourly capsule - strong pain killer fed

DRUG12 hourly capsule strong painkiller with antagonist fasted)

DRUG4 mg 12 hourly capsule strong painkiller with antagonist fed

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics parameters AUC and Cmax	Up to 32 hours

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026