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

NCT02773316 | Completed Phase 1

• 1 other identifier: MR902-1501
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Opioid Substitution Treatment

Outcome Measures

Primary Outcomes (2)

• Measure the observed maximum plasma or serum concentration after administration (Cmax)

  PK plasma parameters

  Pre-dose to 24 hours post-dose

• Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt)

  PK Plasma Parameters

  Pre-dose to 24 hours post-dose

Secondary Outcomes (9)

• measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)

  Pre-dose to 24 hours post-dose

• measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)

  Pre-dose to 24 hours post-dose

• measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)

  Pre-dose to 24 hours post-dose

• Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)

  Pre-dose to 24 hours post-dose

• Measurement of heart rate

  Pre-dose to 24 hours post-dose

Study Arms (3)

MR902 50/0.5 mg

EXPERIMENTAL

MR902 50/0.5 mg PR tablets, single dose oral

Drug: MR902

MR902 200/2 mg

EXPERIMENTAL

MR902 200/2 mg PR tablets, single dose oral

Drug: MR902

IR morphine sulphate 10 mg/5mL solution

ACTIVE COMPARATOR

IR morphine sulphate 10 mg/5mL solution, single dose oral

Drug: IR morphine sulphate

Interventions

MR902 DRUG

MR902 200/2 mg; MR902 50/0.5 mg

IR morphine sulphate DRUG

Also known as: IR morphine sulphate 10 mg/mL solution

IR morphine sulphate 10 mg/5mL solution

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 16, 2016
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share