Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mundipharma Research Limited
• Treatments: Morphine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.

• Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 30.0.

• Willing to eat all the food supplied throughout the study.

• The subject's primary care physician has confirmed within the last 12 months of first dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study.

Exclusion Criteria:

• Female subjects who are pregnant or lactating.

• Any history of drug or alcohol abuse, misuse, physical or psychological dependence.

• Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.

• Use of opioid or opioid antagonist-containing medication in the past 30 days.

• Any history of frequent nausea or vomiting regardless of etiology.

• Any history of seizures or symptomatic head trauma.

• History of respiratory depression, hypoxia or elevated carbon dioxide levels in the blood.

• History of paralytic ileus, gastrointestinal disease or other clinically significant gastrointestinal problems.

• Participation in a clinical drug study during the 90 days preceding the initial dose in this study.

• Any significant illness during the 4 weeks preceding entry into this study.

• Use of any medication including vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose or during the course of this study (with the exception of the continued use of HRT and contraceptives).

• History of smoking within 60 days of IMP administration and refusal to abstain from smoking during the study.