PainPhase 1NCT02089581
A Study of Whether 2 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 Active comparator MR2XXX, MRXXX and MR1XXX in people with Pain, run by Mundipharma Research Limited at 2 sites in United Kingdom.
Trial summary
To determine whether two 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?
- Active comparator MR2XXX, MRXXX and MR1XXX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2014to 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
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects who are sexually active or become sexually active must be willing to use highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device), or vasectomised partner.
- Female subjects less than one year post-menopausal must have a negative serum pregnancy test and be non-lactating.
- Female subjects who have been post-menopausal for > 1 year and have elevated serum follicle-stimulating hormone (FSH) or are treated with hormone replacement therapy (HRT).
- 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 ≤ 29.9.
Show all 9Show fewer
- 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 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.
- Paralytic ileus, respiratory depression, hypoxia or elevated carbon dioxide levels in the blood.
Show all 10Show fewer
- 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 and definitive phase 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). Note: subjects taking oral contraceptives containing CYP3A4 inhibitors such as gestodene should be excluded as this may lead to elevated plasma concentrations.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open-label, Randomised, Crossover, Single-dose, Study in Healthy Subjects to Compare the Pharmacokinetics of Two Formulations of a Strong Pain Killer With a Marketed Reference Product in a Fasted or Fed State
To determine whether two 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 two 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 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
- Active comparator MR2XXX, MRXXX, MR1XXX, MRXXX and MR1XXX
- Keywords
- Healthy Volunteer, Pharmacokinetics, Bioequivalence
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator MR2XXXDrug
Also called MR2XXX
comparison of two new oral formulations with existing formulation
MRXXXDrug
Also called Experimental capsule formulation compared to marketed reference product
MRXXX
MR1XXXDrug
MRXXX and MR1XXXDrug
Also called MRXXX and MR1XXX in fed and fasted state
MRXXX and MR1XXX in fed and fasted state
| Study group | Role | What they receive |
|---|---|---|
| Drug | Active comparator | MR2XXX Receives: Drug: Active comparator MR2XXX |
| MRXXX | Experimental | MRXXX capsule 12 hourly Receives: Drug: MRXXX |
| MR1XXX | Experimental | MR1XXX capsule, 12 hourly Receives: Drug: MR1XXX |
| Experimental | Experimental | Experimental Fed Receives: Drug: MRXXX and MR1XXX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the pharmacokinetics and potential for bioequivalence of two novel formulations
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF).
Measured: Up to 32 hours
The primary objective of the definitive phase is to assess bioequivalence of one or two experimental capsule formulations
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF). Drug Concentration Measurements: Pre-dose on the first day of each study period, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours after dosing (19 samples per study period).
Measured: 32 hours
Secondary outcomes (1)
Assess the safety and tolerability of two experimental formulations of Tablet and Capsule in a fasted and fed state by the collection of adverse events, vital signs, clinical laboratory results and ECGs
Assess the safety and tolerability of two experimental formulations of Tablet and Capsule in a fasted and fed state by the collection of adverse events, vital signs, clinical laboratory results and ECGs
Measured: Up to 32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- 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
- Treatment
- 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
- NCT02089581
- Sponsor's protocol ID
- HMX1508
- Other IDs
- 2013-005523-16
- Status last verified
- Sep 2015
- First submitted
- 20 Feb 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Crossover, Single-dose, Study in Healthy Subjects to Compare the Pharmacokinetics of Two Formulations of a Strong Pain Killer With a Marketed Reference Product in a Fasted or Fed State
- ClinicalTrials.gov ID
- NCT02089581
- Acronym / sponsor ID
- HMX1508
- Conditions
- Pain
- Keywords
- Healthy Volunteer, Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Mar 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 determine whether two 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 two 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 32 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Drug | Active comparator | Drug: Active comparator MR2XXXMR2XXX |
| MRXXX | Experimental | Drug: MRXXXMRXXX capsule 12 hourly |
| MR1XXX | Experimental | Drug: MR1XXXMR1XXX capsule, 12 hourly |
| Experimental | Experimental | Drug: MRXXX and MR1XXXExperimental Fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects who are sexually active or become sexually active must be willing to use highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device), or vasectomised partner.
- Female subjects less than one year post-menopausal must have a negative serum pregnancy test and be non-lactating.
- Female subjects who have been post-menopausal for > 1 year and have elevated serum follicle-stimulating hormone (FSH) or are treated with hormone replacement therapy (HRT).
- 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 (10 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 |
|---|---|---|
| Active comparator MR2XXXAlso: MR2XXXcomparison of two new oral formulations with existing formulation | Drug | Drug |
| MRXXXAlso: Experimental capsule formulation compared to marketed reference productMRXXX | Drug | MRXXX |
| MR1XXX | Drug | MR1XXX |
| MRXXX and MR1XXXAlso: MRXXX and MR1XXX in fed and fasted stateMRXXX and MR1XXX in fed and fasted state | Drug | Experimental |
Primary outcome
Assess the pharmacokinetics and potential for bioequivalence of two novel formulations
Time frame: Up to 32 hours
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF).
The primary objective of the definitive phase is to assess bioequivalence of one or two experimental capsule formulations
Time frame: 32 hours
Areas under the plasma concentration-time curve calculated to the last measurable concentration (AUCt) will be calculated using the linear trapezoidal method. Where possible, the terminal phase rate constants will be estimated using those points determined to be in the terminal log-linear phase. Half-lives (t1/2Z) will be determined from the ratio of ln 2 to LambdaZ. The areas under the plasma concentration-time curve between the last measured point and infinity will be calculated from the ratio of the final observed plasma concentration (Clast) to LambdaZ. This will be added to the AUCt to yield the area under the plasma concentration-time curve between the time of administration and infinity (AUCINF). Drug Concentration Measurements: Pre-dose on the first day of each study period, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24 and 32 hours after dosing (19 samples per study period).
1 secondary outcome
Assess the safety and tolerability of two experimental formulations of Tablet and Capsule in a fasted and fed state by the collection of adverse events, vital signs, clinical laboratory results and ECGs
Time frame: Up to 32 hours
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 28 Sep 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active comparator MR2XXX, MRXXX and MR1XXX in people with Pain, run by Mundipharma Research Limited at 2 sites 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 10 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess the pharmacokinetics and potential for bioequivalence of two novel formulations (time frame: Up to 32 hours). 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 28 Sep 2015.