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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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ClinicalTrials.gov Identifier: NCT02773316
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
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.

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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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov 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:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents