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.

Pain Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133820
• Other study ID #: HMX1507
• Secondary ID: 2013-005522-35
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2014
• Last updated: June 26, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

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

• 4 mg 12 hourly capsule - strong pain killer fed

• 12 hourly capsule strong painkiller with antagonist fasted)

• 4 mg 12 hourly capsule strong painkiller with antagonist fed

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Limited	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters AUC and Cmax		Up to 32 hours	No
Secondary	Adverse Events	AEs will be recorded through spontaneous reporting	7 to 10 days	No
Secondary	Vital Signs	Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate	0 to 32 hours	No
Secondary	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	No
Secondary	ECG	ECGs	Screening, 1 our post-dose and Day 7-10	Yes