Healthy VolunteersPhase 1NCT02966860
Single-Dose PK Study of an Oxycodone/Acetaminophen Solution in Healthy Subjects
A Phase 1 study testing Oral solution OC/APAP in people with Healthy Volunteers, run by Mallinckrodt at 1 site in United States.
Trial summary
A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects under fasted conditions Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Oral solution OC/APAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Nov 2016
- 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
- Subjects must be adequately informed and understands the nature and risks of the study and must be able to provide a signature and date on the informed consent form (ICF).
- Subjects must have a health status of "healthy" assessed by the investigator, defined as no clinically significant deviation from normal in medical history, physical examination, and clinical laboratory determinations.
- Subjects must be males or nonpregnant, nonlactating females, between 18 and 55 years of age (inclusive) at time of the Screening Visit.
- Subjects must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m² with a minimum weight of 110 pounds for females and 130 pounds for males at the Screening Visit. The BMI will be calculated using the standard formula of weight (kg)/(height [m])2.
- Female subjects must have a negative serum pregnancy test at the Screening Visit and check-in to the study site. All female subjects who are biologically capable of having children must agree and commit to the use of 2 acceptable methods of birth control, defined as nonhormonal forms of contraception, condoms or diaphragms with spermicidal foam 14 days prior to check-in to the study site and for the duration of study participation. Unacceptable methods of birth control include abstinence, hormone-containing intrauterine devices, uterine ablation, hormonal forms of contraception, rhythm, and withdrawal methods. Female subjects who are not biologically capable of having children are defined as postmenopausal female subjects who have been amenorrheic for at least 12 consecutive months prior to the Screening Visit or are surgically sterile.
- Male subjects with reproductive potential must agree to use an acceptable method of contraception for the duration of the study (surgical sterilization [vasectomy] or condom with spermicide).
- Subjects must be able to communicate effectively with study personnel.
- Subjects must be able and willing to follow all protocol requirements and study restrictions.
Who cannot join
- A subjects is ineligible for the study if he or she meets any of the following criteria at the Screening Visit or at check-in to the study site:
- Subject is from a vulnerable 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 institutional review board (IRB).
- Subject has a history of any drug allergy, hypersensitivity, or intolerance to any opioids, APAP, or naltrexone 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 a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody.
- Subject has a thyroid-stimulating hormone (TSH) value that is outside the reference range at the Screening Visit.
- Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days, prior to the Screening Visit or plans to donate blood or plasma while enrolled in this study.
Show all 21Show fewer
- Subject has smoked or used nicotine-containing products 6 months prior to the Screening Visit.
- Subject has current or recent (within 2 years of the Screening Visit) drug or alcohol abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Diagnostic Criteria for Drug and Alcohol Abuse.
- Subject has current or recent (within 3 months of the Screening Visit) gastrointestinal (GI) disease (including, but not limited to, peptic ulcer, diverticulitis, bowel obstructions, adhesions, malabsorption, paralytic ileus, gastritis, or diarrhea) or any GI surgery that could impact the absorption of study drug (including, but not limited to, cholecystectomy and gastric bypass or gastric band surgery).
- Subject had any major surgery within 3 months prior to the Screening Visit.
- Subject has a history, or laboratory evidence of, a bleeding or clotting disorder or condition.
- Subject is unable to tolerate venipuncture and/or venous access.
- Subject has any medical, psychiatric and/or social reason for exclusion, as determined by the investigator.
- Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine), cotinine, or alcohol at the Screening Visit or at check-in to the study site.
- Subject used any other investigational medicinal product (study drug) within 30 days prior to the Screening Visit and throughout the duration of the study or plans to participate in another clinical study while concurrently enrolled in this study.
- Subject has taken prescription drugs or over-the-counter (OTC) medications, vitamins, minerals, or dietary/herbal supplements (including grapefruit juice and grapefruit-containing products, St. John's wort and St. John's wort-containing products) within 14 days prior to check-in to the study site and throughout the duration of the study.
- Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
- Subject presents with a history of acute illness within 14 days prior to check-in to the study site and throughout the duration of the study.
- Subject has an electrocardiogram (ECG) parameter (confirmed by repeat evaluation) outside the following limits: PR ≥ 210 ms, QRS ≥ 120 ms, QT ≥ 500 ms; QT interval corrected for heart rate incorporating Bazett's formula (QTcB) ≥ 450 ms.
- Subject has other clinically significant ECG abnormalities, as assessed by the investigator.
- Subject has an oxygen saturation of < 95%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Study Evaluating the Oral Pharmacokinetics of an Oxycodone/Acetaminophen Solution in Healthy Subjects Under Fasted Conditions
A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects under fasted conditions
Read the detailed description
An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap solutions in healthy subjects under fasted conditions
- Conditions
- Healthy Volunteers
- Being tested
- Oral solution OC/APAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral solution OC/APAPDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone and acetaminophen (OC/APAP) | Experimental | Single 15 mL dose of oral solution of OC/APAP (total dose 15 mg oxycodone/975 mg acetaminophen) Receives: Drug: Oral solution OC/APAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t)
Measured: 24 hours
Observed maximum plasma concentration
Measured: 24 hours
Observed time to maximum plasma concentration
Measured: 24 hours
Apparent elimination half-life
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966860
- Sponsor's protocol ID
- MNK15141038
- Status last verified
- Apr 2017
- First submitted
- 6 Nov 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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
- A Single-Dose Study Evaluating the Oral Pharmacokinetics of an Oxycodone/Acetaminophen Solution in Healthy Subjects Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT02966860
- Acronym / sponsor ID
- MNK15141038
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Nov 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 single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects under fasted conditions
Detailed description
An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap solutions in healthy subjects under fasted conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycodone and acetaminophen (OC/APAP) | Experimental | Drug: Oral solution OC/APAPSingle 15 mL dose of oral solution of OC/APAP (total dose 15 mg oxycodone/975 mg acetaminophen) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must be adequately informed and understands the nature and risks of the study and must be able to provide a signature and date on the informed consent form (ICF).
- Subjects must have a health status of "healthy" assessed by the investigator, defined as no clinically significant deviation from normal in medical history, physical examination, and clinical laboratory determinations.
- Subjects must be males or nonpregnant, nonlactating females, between 18 and 55 years of age (inclusive) at time of the Screening Visit.
- Subjects must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m² with a minimum weight of 110 pounds for females and 130 pounds for males at the Screening Visit. The BMI will be calculated using the standard formula of weight (kg)/(height [m])2.
- Female subjects must have a negative serum pregnancy test at the Screening Visit and check-in to the study site. All female subjects who are biologically capable of having children must agree and commit to the use of 2 acceptable methods of birth control, defined as nonhormonal forms of contraception, condoms or diaphragms with spermicidal foam 14 days prior to check-in to the study site and for the duration of study participation. Unacceptable methods of birth control include abstinence, hormone-containing intrauterine devices, uterine ablation, hormonal forms of contraception, rhythm, and withdrawal methods. Female subjects who are not biologically capable of having children are defined as postmenopausal female subjects who have been amenorrheic for at least 12 consecutive months prior to the Screening Visit or are surgically sterile.
Key exclusion criteria (21 listed)
- A subjects is ineligible for the study if he or she meets any of the following criteria at the Screening Visit or at check-in to the study site:
- Subject is from a vulnerable 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 institutional review board (IRB).
- Subject has a history of any drug allergy, hypersensitivity, or intolerance to any opioids, APAP, or naltrexone 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 a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody.
- Subject has a thyroid-stimulating hormone (TSH) value that is outside the reference range at the Screening Visit.
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 |
|---|---|---|
| Oral solution OC/APAP | Drug | Oxycodone and acetaminophen (OC/APAP) |
Primary outcome
Area under the concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t)
Time frame: 24 hours
Observed maximum plasma concentration
Time frame: 24 hours
Observed time to maximum plasma concentration
Time frame: 24 hours
Apparent elimination half-life
Time frame: 24 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 5 Apr 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 Oral solution OC/APAP in people with Healthy Volunteers, 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 21 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 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 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?
Area under the concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t) (time frame: 24 hours). The study lists 4 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 5 Apr 2017.