Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution

Opioid Substitution Treatment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773316
• Other study ID #: MR902-1501
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2016
• Last updated: May 13, 2016
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Substitution Treatment

Intervention

Drug:
• MR902

• IR morphine sulphate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the observed maximum plasma or serum concentration after administration (Cmax)	PK plasma parameters	Pre-dose to 24 hours post-dose	No
Primary	Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt)	PK Plasma Parameters	Pre-dose to 24 hours post-dose	No
Secondary	measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)	PK plasma parameters	Pre-dose to 24 hours post-dose	No
Secondary	measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)	PK plasma parameters	Pre-dose to 24 hours post-dose	No
Secondary	measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)	PK plasma parameters	Pre-dose to 24 hours post-dose	No
Secondary	Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)	PK plasma parameters	Pre-dose to 24 hours post-dose	No
Secondary	Measurement of heart rate	Vital signs measurements	Pre-dose to 24 hours post-dose	No
Secondary	Measurement of blood pressure	vital signs measurement	pre-dose to 24 hours post-dose	No
Secondary	Measurement of respiration rate	vital signs measurement	pre-dose to 24 hours post-dose	No
Secondary	Measurement of temperature	vital signs measurement	pre-dose to 24 hours post-dose	No
Secondary	Measurement of Saturation Pulse Oxygen (SP02)	vital signs measurement	pre-dose to 24 hours post-dose	No