Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
Phase 1
Completed
- Conditions
- Opioid Substitution Treatment
- Interventions
- Registration Number
- NCT02773316
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IR morphine sulphate 10 mg/5mL solution IR morphine sulphate IR morphine sulphate 10 mg/5mL solution, single dose oral MR902 200/2 mg MR902 MR902 200/2 mg PR tablets, single dose oral MR902 50/0.5 mg MR902 MR902 50/0.5 mg PR tablets, single dose oral
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 blood pressure pre-dose to 24 hours post-dose vital signs measurement
Measurement of respiration rate 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
measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,) 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 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 Pharmacokinetic parameter elimination of half life after administration ( t1/2Z) Pre-dose to 24 hours post-dose PK plasma parameters