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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

Tracking Information
First Submitted Date  ICMJE May 10, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • Measure the observed maximum plasma or serum concentration after administration (Cmax) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • 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
  • measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters
  • measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters
  • Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z) [ Time Frame: Pre-dose to 24 hours post-dose ]
    PK plasma parameters
  • Measurement of heart rate [ Time Frame: Pre-dose to 24 hours post-dose ]
    Vital signs measurements
  • Measurement of blood pressure [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement
  • Measurement of respiration rate [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement
  • Measurement of temperature [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement
  • Measurement of Saturation Pulse Oxygen (SP02) [ Time Frame: pre-dose to 24 hours post-dose ]
    vital signs measurement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
Official Title  ICMJE 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
Brief Summary A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Substitution Treatment
Intervention  ICMJE
  • Drug: MR902
  • Drug: IR morphine sulphate
    Other Name: IR morphine sulphate 10 mg/mL solution
Study Arms  ICMJE
  • Experimental: MR902 50/0.5 mg
    MR902 50/0.5 mg PR tablets, single dose oral
    Intervention: Drug: MR902
  • Experimental: MR902 200/2 mg
    MR902 200/2 mg PR tablets, single dose oral
    Intervention: Drug: MR902
  • Active Comparator: IR morphine sulphate 10 mg/5mL solution
    IR morphine sulphate 10 mg/5mL solution, single dose oral
    Intervention: Drug: IR morphine sulphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773316
Other Study ID Numbers  ICMJE MR902-1501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mundipharma Research Limited
Study Sponsor  ICMJE Mundipharma Research Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mundipharma Research Limited
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP