Clinical trial NCT02773316: Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Substitution Treatment
Lead sponsor: Mundipharma Research Limited
Sponsor class: INDUSTRY
First posted: 2016-05-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Measure the observed maximum plasma or serum concentration after administration (Cmax)
timeFrame: Pre-dose to 24 hours post-dose
measure: Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt)
timeFrame: Pre-dose to 24 hours post-dose
Secondary outcomes:
measure: measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)
timeFrame: Pre-dose to 24 hours post-dose
measure: measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)
timeFrame: Pre-dose to 24 hours post-dose
measure: measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)
timeFrame: Pre-dose to 24 hours post-dose
measure: Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)
timeFrame: Pre-dose to 24 hours post-dose
measure: Measurement of heart rate
timeFrame: Pre-dose to 24 hours post-dose
measure: Measurement of blood pressure
timeFrame: pre-dose to 24 hours post-dose
measure: Measurement of respiration rate
timeFrame: pre-dose to 24 hours post-dose
measure: Measurement of temperature
timeFrame: pre-dose to 24 hours post-dose
measure: Measurement of Saturation Pulse Oxygen (SP02)
timeFrame: pre-dose to 24 hours post-dose
Other outcomes:
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