Opioid Substitution TreatmentPhase 1NCT02773316
Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
A Phase 1 study testing MR902 and IR morphine sulphate in people with Opioid Substitution Treatment, run by Mundipharma Research Limited.
Trial summary
A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Substitution Treatment
- What is being tested?
- MR902 and IR morphine sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
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
A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption
Read the 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.
- Conditions
- Opioid Substitution Treatment
- Being tested
- MR902, IR morphine sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR902Drug
IR morphine sulphateDrug
Also called IR morphine sulphate 10 mg/mL solution
| Study group | Role | What they receive |
|---|---|---|
| MR902 50/0.5 mg | Experimental | MR902 50/0.5 mg PR tablets, single dose oral Receives: Drug: MR902 |
| MR902 200/2 mg | Experimental | MR902 200/2 mg PR tablets, single dose oral Receives: Drug: MR902 |
| IR morphine sulphate 10 mg/5mL solution | Active comparator | IR morphine sulphate 10 mg/5mL solution, single dose oral Receives: Drug: IR morphine sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the observed maximum plasma or serum concentration after administration (Cmax)
PK plasma parameters
Measured: Pre-dose to 24 hours post-dose
Measure the area under the concentration-time curve from zero up to a definite time t after administration (AUCt)
PK Plasma Parameters
Measured: Pre-dose to 24 hours post-dose
Secondary outcomes (9)
measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)
PK plasma parameters
Measured: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)
PK plasma parameters
Measured: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)
PK plasma parameters
Measured: Pre-dose to 24 hours post-dose
Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)
PK plasma parameters
Measured: Pre-dose to 24 hours post-dose
Measurement of heart rate
Vital signs measurements
Measured: Pre-dose to 24 hours post-dose
Measurement of blood pressure
vital signs measurement
Measured: pre-dose to 24 hours post-dose
Measurement of respiration rate
vital signs measurement
Measured: pre-dose to 24 hours post-dose
Measurement of temperature
vital signs measurement
Measured: pre-dose to 24 hours post-dose
Measurement of Saturation Pulse Oxygen (SP02)
vital signs measurement
Measured: pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Substitution TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773316
- Sponsor's protocol ID
- MR902-1501
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02773316
- Acronym / sponsor ID
- MR902-1501
- Conditions
- Opioid Substitution Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MR902 50/0.5 mg | Experimental | Drug: MR902MR902 50/0.5 mg PR tablets, single dose oral |
| MR902 200/2 mg | Experimental | Drug: MR902MR902 200/2 mg PR tablets, single dose oral |
| IR morphine sulphate 10 mg/5mL solution | Active comparator | Drug: IR morphine sulphateIR morphine sulphate 10 mg/5mL solution, single dose oral |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR902 | Drug | MR902 200/2 mg, MR902 50/0.5 mg |
| IR morphine sulphateAlso: IR morphine sulphate 10 mg/mL solution | Drug | IR morphine sulphate 10 mg/5mL solution |
Primary outcome
Measure the observed maximum plasma or serum concentration after administration (Cmax)
Time frame: 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)
Time frame: Pre-dose to 24 hours post-dose
PK Plasma Parameters
9 secondary outcomes
measurement of Pharmacokinetic parameter Area under the curve to infinity after administration (AUCINF)
Time frame: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter time to maximum concentration after administration (tmax)
Time frame: Pre-dose to 24 hours post-dose
measurement of Pharmacokinetic parameter of elimination rate after administration (LambdaZ,)
Time frame: Pre-dose to 24 hours post-dose
Measurement of Pharmacokinetic parameter elimination of half life after administration ( t1/2Z)
Time frame: Pre-dose to 24 hours post-dose
Measurement of heart rate
Time frame: Pre-dose to 24 hours post-dose
Measurement of blood pressure
Time frame: pre-dose to 24 hours post-dose
Measurement of respiration rate
Time frame: pre-dose to 24 hours post-dose
Measurement of temperature
Time frame: pre-dose to 24 hours post-dose
Measurement of Saturation Pulse Oxygen (SP02)
Time frame: pre-dose to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Individual participant dataSharing planned: No
Related trials for Opioid Substitution Treatment
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
Enrolling by invitation
Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
Opioid-Related Disorders, Mobile Applications
Recruiting
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
Hepatitis C
Recruiting
Opioids, Low Nicotine Cigarettes, and Chronic Pain
Chronic Pain, Tobacco Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MR902 and IR morphine sulphate in people with Opioid Substitution Treatment, run by Mundipharma Research Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the observed maximum plasma or serum concentration after administration (Cmax) (time frame: Pre-dose to 24 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.