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

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Mundipharma

Status and phase

Completed
Phase 1

Conditions

Opioid Substitution Treatment

Treatments

Drug: IR morphine sulphate
Drug: MR902

Study type

Interventional

Funder types

Industry

Identifiers

NCT02773316
MR902-1501

Details and patient eligibility

About

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

Full description

Volunteers will receive a single dose of the investigational drug on 2 occasions and a reference drug on 1 occasion. Volunteers will be randomised to one of two groups, each group receiving a different dose strength of MR902 in fed and fasted state.

The study involves a screening visit 21 days before first dosing and 3 overnight stays in 3 study periods, and a post-study medical visit.

Volunteers will receive naltrexone to reduce anticipated opioid side effects.

Enrollment

84 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

84 participants in 3 patient groups

MR902 50/0.5 mg
Experimental group
Description:
MR902 50/0.5 mg PR tablets, single dose oral
Treatment:
Drug: MR902
MR902 200/2 mg
Experimental group
Description:
MR902 200/2 mg PR tablets, single dose oral
Treatment:
Drug: MR902
IR morphine sulphate 10 mg/5mL solution
Active Comparator group
Description:
IR morphine sulphate 10 mg/5mL solution, single dose oral
Treatment:
Drug: IR morphine sulphate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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