Acute PainPhase 1NCT02767349

Pharmacokinetics and Safety of MNK-155 in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain

A Phase 1 study testing MNK-155 in people with Acute Pain, run by Mallinckrodt at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of MNK-155 in this population. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Acute Pain
What is being tested?: MNK-155
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Jun 2017
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject must be male or nonpregnant, nonlactating females between 12 and 17 years of age (inclusive) at time of screening.
Subject must have a minimum weight of 100 pounds (45 kg) at the time of screening and have a body mass index (BMI) > 5% and < 95% for their age at the time of screening.
Subject must report having moderate or severe acute pain (as determined from the Numerical Pain Rating scale (NPRS) where 0 = no pain, 10 = worst pain; subjects must have a level of 4 or more) after a pediatric surgical procedure (at baseline) that requires hospitalization. Sponsor will pre-approve a list of acceptable surgical procedures prior to study start for each site. Surgical procedures other than those on the pre-approved list may be acceptable on a case by case basis if approved by the medical monitor (MM) and sponsor.
Subject, if female of child-bearing potential (defined as postmenarche), must agree to abstain from unprotected sexual activity during study participation and for 2 weeks after study exit/early termination.
Subject, if male with reproductive potential, must agree to abstain from unprotected sexual activity during study participation and for 2 weeks after study exit/early termination.
Subject, if female of childbearing potential, must have negative pregnancy test (serum or urine) results at screening and check-in.
Subject's legally authorized representative (eg, parent, legal guardian) must voluntarily sign and date a parental permission/ Informed Consent that is approved by an Institutional Review Board (IRB), and the subject must sign an IRB approved assent, before undergoing any protocol specific procedures or assessments.
Subject and the subject's parent or legal guardian must be able to read, understand, and be willing to follow the study procedures and requirements and communicate meaningfully in English with the investigator and investigator's staff (if the subject cannot read or communicate meaningfully, then the subject's legally authorized representative [eg, parent, legal guardian] must meet this criterion).

Who cannot join

Subject is from a vulnerable population (including mentally disabled children), other than a pediatric population, as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB.
Subject is expected to require a surgery that could influence the study outcome (eg, ventriculoperitoneal shunt repair in the setting of hydrocephalus).
Subject has an abnormal electrocardiogram (ECG) unless the investigator determines the ECG abnormalities are not clinically significant.
Subject has a screening pulse oximetry reading of < 95% while awake.
Subject has a history of laboratory test results obtained before screening that show the presence of human immunodeficiency virus (HIV), hepatitis B surface antigen, hepatitis C antibody, or active hepatitis A immunoglobulin M.
Subject has laboratory values that are greater than 2 times the upper limit of normal (with the exception of white blood cell [WBC] differential values). Enrollment of subjects with laboratory values that are between 1 and 2 times the upper limit of normal (ULN), or below the lower limit of normal, or white blood cells (WBC) differential > 2 x ULN , will be left to the investigator's discretion (no increased risk of participation in study based upon judgment of the investigator).

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Subject has any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject has significantly impaired renal function, in the opinion of the investigator as evidenced by an estimated glomerular filtration rate calculated using a pediatric appropriate formula such as the Schwartz Equation (Schwartz et al, 2009).
Subject has a history or laboratory evidence of bleeding or clotting disorders or conditions.
Subject has a known or suspected history of alcoholism, marijuana or illicit drug abuse or misuse within 2 years before screening as evidence from medical history or evidence of tolerance or physical dependence before the first dose of MNK-155.
Subject has smoked or used nicotine-containing products within 6 months prior to screening as evidenced by medical history.
Subject has a history of psychiatric disorders, such as major depression disorder, anxiety disorders, or psychotic disorders requiring hospitalization and/or medication within 6 months prior to screening. A history of attention deficit hyperactivity disorder requiring medication is acceptable.
Subject has a diagnosis of epilepsy or other seizure disorder (a history of febrile seizures is acceptable).
Subject has had previous cardiothoracic surgery (subjects who have a history of patent ductus arteriosus ligations/surgery as infants are acceptable).
Subject has a history of conditions which might be specifically contraindicated or require caution while using hydrocodone bitartrate (HB), acetaminophen (APAP), and/or ibuprofen (if used as rescue medication) per the Investigator's Brochure (IB) and product information per the appropriate package insert.
Subject has a history of any drug allergy, hypersensitivity, or intolerance including HB, APAP, ibuprofen or excipients, or any opioid drug product which, in the opinion of the investigator, would place the subject at particular risk and compromise the safety of the subject in the study.
Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days of screening (unless they have received a transfusion and have hematocrit and hemoglobin within the reference range at screening), or plans to donate blood or plasma during the course of the study.
Subject has a documented history of any pathologic, iatrogenic or surgical conditions that, in the opinion of the investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete MNK-155, including (but not limited to) intractable nausea and/or vomiting, severe GI narrowing, perforation, obstruction, bleed, or gastric band surgery.
Subject has a history of a GI event (eg, perforation, obstruction, bleed) within 6 months prior to screening or any GI event greater than 6 months before screening that, in the opinion of the investigator, would make the subject unsuitable for study participation.
Subject has received any investigational product or device within 30 days before screening, or is scheduled to receive an investigational device or another investigational drug (other than those in this study) during the course of this study.
Subject has used any product containing hydrocodone or APAP within 48 hours prior to the first dose of MNK-155.
Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of APAP or HB, including hypersensitivity to HB, or debilitated patients, those with severe impairment of hepatic, pulmonary, or renal function, myxedema or hypothyroidism, adrenocortical insufficiency (Addison's disease), central nervous system (CNS) depression or coma, toxic psychosis, urethral stricture, acute alcoholism, delirium tremens, severe kyphoscoliosis, or biliary tract dysfunction.
Subject has any other medical condition, abnormal vital sign (blood pressure, pulse rate, respiratory rate), body temperature, pulse oximetry; or any physical examination or ECG finding at screening which, in the investigator's medical opinion, would preclude safe participation in a clinical study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Health Systems
Durham, North Carolina, 27710

Other trials in United States

About this study

Conditions: Acute Pain
Being tested: MNK-155
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MNK-155Drug
2 or 3 tablets initial dose, followed by two tablets every twelve hours

Study groups in NCT02767349
Study group	Role	What they receive
MNK-155	Experimental	MNK-155, initial dose of two or three tablets followed by 2 tablets every 12 hours up to a maximum of five doses. Receives: Drug: MNK-155

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to reach steady state
Measured: 12 Hours
Area under the curve
Area under the concentration time curves after the first and last dose
Measured: 12 Hours
Peak exposure
Measured: 12 Hours
Half-life
Apparent elimination half-life
Measured: 12 Hours
Time to peak exposure
Observed time when peak exposure occurred
Measured: 12 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jun 2017

First posted10 May 2016 (estimated)
Study startJan 2016
Primary completionApr 2017 (estimated)
Study completionJun 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02767349
Sponsor's protocol ID: MNK15041015
Status last verified: Apr 2017
First submitted: 29 Apr 2016
Last updated: 5 Apr 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
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REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Safety of MNK-155 in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
ClinicalTrials.gov ID: NCT02767349
Acronym / sponsor ID: MNK15041015
Conditions: Acute Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Apr 2017 (estimated)
Study completion: Jun 2017 (estimated)
First posted: 10 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MNK-155	Experimental	Drug: MNK-155MNK-155, initial dose of two or three tablets followed by 2 tablets every 12 hours up to a maximum of five doses.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Subject must be male or nonpregnant, nonlactating females between 12 and 17 years of age (inclusive) at time of screening.
Subject must have a minimum weight of 100 pounds (45 kg) at the time of screening and have a body mass index (BMI) > 5% and < 95% for their age at the time of screening.
Subject must report having moderate or severe acute pain (as determined from the Numerical Pain Rating scale (NPRS) where 0 = no pain, 10 = worst pain; subjects must have a level of 4 or more) after a pediatric surgical procedure (at baseline) that requires hospitalization. Sponsor will pre-approve a list of acceptable surgical procedures prior to study start for each site. Surgical procedures other than those on the pre-approved list may be acceptable on a case by case basis if approved by the medical monitor (MM) and sponsor.
Subject, if female of child-bearing potential (defined as postmenarche), must agree to abstain from unprotected sexual activity during study participation and for 2 weeks after study exit/early termination.
Subject, if male with reproductive potential, must agree to abstain from unprotected sexual activity during study participation and for 2 weeks after study exit/early termination.

Key exclusion criteria (22 listed)

Subject is from a vulnerable population (including mentally disabled children), other than a pediatric population, as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB.
Subject is expected to require a surgery that could influence the study outcome (eg, ventriculoperitoneal shunt repair in the setting of hydrocephalus).
Subject has an abnormal electrocardiogram (ECG) unless the investigator determines the ECG abnormalities are not clinically significant.
Subject has a screening pulse oximetry reading of < 95% while awake.
Subject has a history of laboratory test results obtained before screening that show the presence of human immunodeficiency virus (HIV), hepatitis B surface antigen, hepatitis C antibody, or active hepatitis A immunoglobulin M.

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
MNK-1552 or 3 tablets initial dose, followed by two tablets every twelve hours	Drug	MNK-155

Primary outcome

Time to reach steady state
Time frame: 12 Hours
Area under the curve
Time frame: 12 Hours
Area under the concentration time curves after the first and last dose
Peak exposure
Time frame: 12 Hours
Half-life
Time frame: 12 Hours
Apparent elimination half-life
Time to peak exposure
Time frame: 12 Hours
Observed time when peak exposure occurred

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

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 MNK-155 in people with Acute Pain, run by Mallinckrodt at 1 site in United States.

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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 5 Apr 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 States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Time to reach steady state (time frame: 12 Hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767349.

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 5 Apr 2017.