PainPhase 1NCT02133820
A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.
A Phase 1 study testing 4 mg 12 hourly capsule - strong pain killer fasted, 4 mg 12 hourly capsule - strong pain killer fed and 12 hourly capsule strong painkiller with antagonist fasted) in people with Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 4 mg 12 hourly capsule - strong pain killer fasted, 4 mg 12 hourly capsule - strong pain killer fed and 12 hourly capsule strong painkiller with antagonist fasted)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Jun 2014
- 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
Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Limited
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
Read the detailed description
This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
- Conditions
- Pain
- Being tested
- 4 mg 12 hourly capsule - strong pain killer fasted, 4 mg 12 hourly capsule - strong pain killer fed, 12 hourly capsule strong painkiller with antagonist fasted), 4 mg 12 hourly capsule strong painkiller with antagonist fed
- Keywords
- Healthy Volunteer, Pharmacokinetics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg 12 hourly capsule - strong pain killer fastedDrug
Also called MR2XXX
4 mg 12 hourly capsule - strong pain killer fedDrug
Also called MR2XXX
12 hourly capsule strong painkiller with antagonist fasted)Drug
Also called MR2XXX
4 mg 12 hourly capsule strong painkiller with antagonist fedDrug
Also called MR2XXX
| Study group | Role | What they receive |
|---|---|---|
| 12 hourly capsule fasted | Active comparator | 4 mg 12 hourly capsule - strong pain killer fasted Receives: Drug: 4 mg 12 hourly capsule - strong pain killer fed |
| 12 hourly capsule fed | Active comparator | 4 mg 12 hourly capsule - strong pain killer fed Receives: Drug: 4 mg 12 hourly capsule - strong pain killer fasted |
| 12 hourly capsule with antagonist fasted | Experimental | 4 mg 12 hourly capsule strong painkiller with antagonist fasted Receives: Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed |
| 12 hourly capsule with antagonist fed | Experimental | 4 mg 12 hourly capsule strong painkiller with antagonist fed Receives: Drug: 12 hourly capsule strong painkiller with antagonist fasted) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters AUC and Cmax
Measured: Up to 32 hours
Secondary outcomes (4)
Adverse Events
AEs will be recorded through spontaneous reporting
Measured: 7 to 10 days
Vital Signs
Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate
Measured: 0 to 32 hours
Clinical Laboratory Tests
Clinical laboratory tests - blood samples will be taken at screening and post-study medical for routine laboratory analysis (haematology, blood chemistry and urinalysis
Measured: Day 0 and Day 7-10
ECG
ECGs
Measured: Screening, 1 our post-dose and Day 7-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02133820
- Sponsor's protocol ID
- HMX1507
- Other IDs
- 2013-005522-35
- Status last verified
- Jun 2014
- First submitted
- 25 Feb 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.
- ClinicalTrials.gov ID
- NCT02133820
- Acronym / sponsor ID
- HMX1507
- Conditions
- Pain
- Keywords
- Healthy Volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 May 2014 (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.
To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
Detailed description
This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12 hourly capsule fasted | Active comparator | Drug: 4 mg 12 hourly capsule - strong pain killer fed4 mg 12 hourly capsule - strong pain killer fasted |
| 12 hourly capsule fed | Active comparator | Drug: 4 mg 12 hourly capsule - strong pain killer fasted4 mg 12 hourly capsule - strong pain killer fed |
| 12 hourly capsule with antagonist fasted | Experimental | Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed4 mg 12 hourly capsule strong painkiller with antagonist fasted |
| 12 hourly capsule with antagonist fed | Experimental | Drug: 12 hourly capsule strong painkiller with antagonist fasted)4 mg 12 hourly capsule strong painkiller with antagonist fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| 4 mg 12 hourly capsule - strong pain killer fastedAlso: MR2XXX | Drug | 12 hourly capsule fed |
| 4 mg 12 hourly capsule - strong pain killer fedAlso: MR2XXX | Drug | 12 hourly capsule fasted |
| 12 hourly capsule strong painkiller with antagonist fasted)Also: MR2XXX | Drug | 12 hourly capsule with antagonist fed |
| 4 mg 12 hourly capsule strong painkiller with antagonist fedAlso: MR2XXX | Drug | 12 hourly capsule with antagonist fasted |
Primary outcome
Pharmacokinetics parameters AUC and Cmax
Time frame: Up to 32 hours
4 secondary outcomes
Adverse Events
Time frame: 7 to 10 days
Vital Signs
Time frame: 0 to 32 hours
Clinical Laboratory Tests
Time frame: Day 0 and Day 7-10
ECG
Time frame: Screening, 1 our post-dose and Day 7-10
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 27 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4 mg 12 hourly capsule - strong pain killer fasted, 4 mg 12 hourly capsule - strong pain killer fed and 12 hourly capsule strong painkiller with antagonist fasted) in people with Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pharmacokinetics parameters AUC and Cmax (time frame: Up to 32 hours). 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 27 Jun 2014.