PainPhase 1NCT02446561
A Study of Whether 3 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
A Phase 1 study testing MRXXX, MR1XXX and MR2XXX in people with Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
To determine whether three new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food 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?
- MRXXX, MR1XXX and MR2XXX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Jul 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
- Provide written informed consent.
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects of child bearing potential must be willing to use two highly effective methods of contraception throughout the study, one of which must include a barrier method.
- Female subjects who are post-menopausal (defined as spontaneous amenorrhea for at least a year) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). These subjects are not required to use any contraception.
- Male subjects must be willing to use contraception with their partners throughout the study and for 30 days after completion of the study and agree to inform the Investigator if their partner becomes pregnant during this time.
- Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 30.0.
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- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- 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
- Any history of drug or alcohol abuse.
- 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.
- Any history of paralytic ileus, respiratory depression, hypoxia or elevated carbon dioxide levels in the blood.
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- Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
- Subjects must not participate in both the pilot phase and the definitive phase of the study, or in more than one Cohort.
- 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).
- Refusal to abstain from food 8 hours preceding and 4 hours following study drug administration, to abstain from foods containing poppy seeds 48 hours preceding and entirely during each confinement, and to abstain from caffeine or xanthine containing food or beverages and grapefruit juice within 48 hours before IMP administration and for the duration of study confinement until after the last study PK sample has been taken in each study period.
- Weekly alcohol intake exceeding the equivalent of 14 units/week for females and 21 units/week for males. (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Consumption of alcoholic beverages within 48 hours before study drug administration, and refusal to abstain from alcohol for the duration of the study confinement and for at least 48 hours after the last naltrexone dose in each study period.
- History of smoking within 45 days of study drug administration and refusal to abstain from smoking during the study.
- Blood or blood products donated within 90 days prior to study drug administration or any time during the study, except as required by this protocol.
- Positive results of urine drug screen, alcohol test, pregnancy test, HBsAg, Hepatitis C antibody, or HIV tests.
- Refusal to allow their primary care physician to be informed of participation in the trial.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether three new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food
Read the detailed description
Comparisons will be made between three new oral formulations and an existing marketed reference capsule formulation to determine whether the release rates of the products are similar or equivalent in a fed or fasted state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 72 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
- MRXXX, MR1XXX, MR2XXX, MR3XXX
- 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.
MRXXXDrug
MR1XXXDrug
MR2XXXDrug
MR3XXXDrug
| Study group | Role | What they receive |
|---|---|---|
| MRXXX | Active comparator | Active comparator Receives: Drug: MRXXX |
| MR1XXX | Experimental | MR1XXX Receives: Drug: MR1XXX |
| MR2XXX | Experimental | MR2XXX Receives: Drug: MR2XXX |
| MR3XXX | Experimental | MR3XXX Receives: Drug: MR3XXX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence as measured by PK parameters
AUCt, AUCINF, LambdaZ, t1/2Z, Cmax and tmax
Measured: Up to 72 hours
Secondary outcomes (1)
Safety and tolerability as measured by adverse events, vital signs, clinical lab results and ECGs.
Collection of adverse events, vital signs, clinical lab results and ECGs.
Measured: Up to 7-10 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT02446561
- Sponsor's protocol ID
- HMX1509
- Status last verified
- Aug 2017
- First submitted
- 22 Apr 2015
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Whether 3 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
- ClinicalTrials.gov ID
- NCT02446561
- Acronym / sponsor ID
- HMX1509
- Conditions
- Pain
- Keywords
- Healthy Volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 May 2015 (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 determine whether three new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food
Detailed description
Comparisons will be made between three new oral formulations and an existing marketed reference capsule formulation to determine whether the release rates of the products are similar or equivalent in a fed or fasted state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 72 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MRXXX | Active comparator | Drug: MRXXXActive comparator |
| MR1XXX | Experimental | Drug: MR1XXXMR1XXX |
| MR2XXX | Experimental | Drug: MR2XXXMR2XXX |
| MR3XXX | Experimental | Drug: MR3XXXMR3XXX |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provide written informed consent.
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects of child bearing potential must be willing to use two highly effective methods of contraception throughout the study, one of which must include a barrier method.
- Female subjects who are post-menopausal (defined as spontaneous amenorrhea for at least a year) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). These subjects are not required to use any contraception.
- Male subjects must be willing to use contraception with their partners throughout the study and for 30 days after completion of the study and agree to inform the Investigator if their partner becomes pregnant during this time.
Key exclusion criteria (18 listed)
- Any history of drug or alcohol abuse.
- 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.
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 |
|---|---|---|
| MRXXX | Drug | MRXXX |
| MR1XXX | Drug | MR1XXX |
| MR2XXX | Drug | MR2XXX |
| MR3XXX | Drug | MR3XXX |
Primary outcome
Bioequivalence as measured by PK parameters
Time frame: Up to 72 hours
AUCt, AUCINF, LambdaZ, t1/2Z, Cmax and tmax
1 secondary outcome
Safety and tolerability as measured by adverse events, vital signs, clinical lab results and ECGs.
Time frame: Up to 7-10 days after last 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 31 Aug 2017.
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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 MRXXX, MR1XXX and MR2XXX 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?
The sponsor lists 9 inclusion and 18 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 31 Aug 2017. 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?
Bioequivalence as measured by PK parameters (time frame: Up to 72 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 31 Aug 2017.