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.

Mundipharma

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: 12 hourly capsule strong painkiller with antagonist fasted); Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed; Drug: 4 mg 12 hourly capsule - strong pain killer fasted; Drug: 4 mg 12 hourly capsule - strong pain killer fed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02133820

2013-005522-35 (EudraCT Number)

HMX1507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

16 participants in 4 patient groups

12 hourly capsule fasted

Active Comparator group

Description:

4 mg 12 hourly capsule - strong pain killer fasted

Treatment:

Drug: 4 mg 12 hourly capsule - strong pain killer fed

12 hourly capsule fed

Active Comparator group

Description:

4 mg 12 hourly capsule - strong pain killer fed

Treatment:

Drug: 4 mg 12 hourly capsule - strong pain killer fasted

12 hourly capsule with antagonist fasted

Experimental group

Description:

4 mg 12 hourly capsule strong painkiller with antagonist fasted

Treatment:

Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed

12 hourly capsule with antagonist fed

Experimental group

Description:

4 mg 12 hourly capsule strong painkiller with antagonist fed

Treatment:

Drug: 12 hourly capsule strong painkiller with antagonist fasted)