PK, Bioavailability and Food Effect Study on MR902
Research type
Research Study
Full title
A 2-cohort, 3-part, open-label, randomised, single dose, crossover study in healthy subjects to compare the pharmacokinetics and bioavailability of a single dose, in a fed and fasted state, of MR902 prolonged-release tablets 50/0.5 mg and 200/2 mg with immediate-release morphine sulphate oral solution (10 mL of a 10 mg/5 mL solution).
IRAS ID
188139
Contact name
Jo Woodward
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2015-002262-23
Duration of Study in the UK
0 years, 2 months, 14 days
Research summary
The purpose of this study is to assess bioavailability (the degree and rate at which the drug is absorbed into the body) of a single dose of the study drug and to assess the effect of food on absorption. This is an open-label design study in which volunteers receive a single dose of the investigational drug on 2 occasions and a reference drug on 1 occasion. It will involve 2 groups of healthy female and male volunteers, 42 per group.
The study will assess the investigational drug as a 100:1 ratio combination of opioid:opioid antagonist in two dose strengths (50/0.5 mg and 200/2 mg). Both groups will receive either 50/0.5 mg or 200/2 mg dose strength, on one occasion in a fed state and on one occasion in a fasted state to enable comparisons on the effect of food on both dose strengths.
Volunteers will attend a screening visit 21 days before checking into the study unit when they will be enrolled into one of 2 groups. In each study period, they will stay in the study unit from check in on the day before study drug administration, until post dose assessments on Day 3. They will return for further procedures on Day 4.
Volunteers will participate in all 3 periods but only in the one group they are assigned to. They will receive the investigational treatment in either a fed or fasted state.
Each group will also receive a dose of immediate release opioid oral solution (reference drug) to enable comparison between this and the prolonged release of the study drug. Naltrexone will be co-administered to reduce opioid effects.
There will be a minimum of 7 days between dosing in each study period.
The duration of the study for each volunteer will be up to 42 days.
REC name
HSC REC A
REC reference
15/NI/0173
Date of REC Opinion
7 Sep 2015
REC opinion
Further Information Favourable Opinion