Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02773316
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):
Mundipharma Research Limited

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

Condition or disease Intervention/treatment Phase
Opioid Substitution Treatment Drug: MR902 Drug: IR morphine sulphate Phase 1

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 2-cohort, 3-part, Open-label, Randomised, Single Dose, Crossover Study in Healthy Subjects to Compare PK & Bioavailability of a Single Dose, in Fed and Fasted State, of MR902 Prolonged Release (PR) Tablets With Immediate Release (IR) Morphine Sulfate Oral Solution
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MR902 50/0.5 mg
MR902 50/0.5 mg PR tablets, single dose oral
Drug: MR902
Experimental: MR902 200/2 mg
MR902 200/2 mg PR tablets, single dose oral
Drug: MR902
Active Comparator: IR morphine sulphate 10 mg/5mL solution
IR morphine sulphate 10 mg/5mL solution, single dose oral
Drug: IR morphine sulphate
Other Name: IR morphine sulphate 10 mg/mL solution

Primary Outcome Measures :
  1. Measure the observed maximum plasma or serum concentration after administration (Cmax) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters

  2. Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK Plasma Parameters

Secondary Outcome Measures :
  1. measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters

  2. measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters

  3. measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters

  4. Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters

  5. Measurement of heart rate [ Time Frame: Pre-dose to 24 hours post-dose ]
    Vital signs measurements

  6. Measurement of blood pressure [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement

  7. Measurement of respiration rate [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement

  8. Measurement of temperature [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement

  9. Measurement of Saturation Pulse Oxygen (SP02) [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Layout table for additonal information
Responsible Party: Mundipharma Research Limited Identifier: NCT02773316    
Other Study ID Numbers: MR902-1501
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents