Opioid Substitution Treatment
Conditions
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.
Interventions
DRUGMR902
DRUGIR morphine sulphate
Sponsors
Mundipharma Research Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the observed maximum plasma or serum concentration after administration (Cmax) | 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) | Pre-dose to 24 hours post-dose | PK Plasma Parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,) | Pre-dose to 24 hours post-dose | PK plasma parameters |
| Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z) | Pre-dose to 24 hours post-dose | PK plasma parameters |
| Measurement of heart rate | Pre-dose to 24 hours post-dose | Vital signs measurements |
| measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF) | Pre-dose to 24 hours post-dose | PK plasma parameters |
| Measurement of respiration rate | pre-dose to 24 hours post-dose | vital signs measurement |
| Measurement of temperature | pre-dose to 24 hours post-dose | vital signs measurement |
| Measurement of Saturation Pulse Oxygen (SP02) | pre-dose to 24 hours post-dose | vital signs measurement |
| Measurement of blood pressure | pre-dose to 24 hours post-dose | vital signs measurement |
| measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax) | Pre-dose to 24 hours post-dose | PK plasma parameters |
Outcome results
None listed