AnalgesiaPhase 1NCT01530542
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
A Phase 1 study testing oxycodone hydrochloride and marketed oxycodone hydrochloride in people with Analgesia and Acute Pain, run by Pfizer at 1 site in United States.
Trial summary
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Acute Pain, Chronic Pain
- What is being tested?
- oxycodone hydrochloride and marketed oxycodone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2010
- 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 between 18 and 55 years of age (inclusive)
Who cannot join
- Evidence or history of clinically significant disease;
- History of obstructive sleep apnea;
- Positive urine drug test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
San Antonio, Texas, 78217
About this study
Official title: Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders
- Being tested
- oxycodone hydrochloride, marketed oxycodone hydrochloride
- Keywords
- bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain
- Medical subject headings
- Agnosia, Acute Pain, Chronic Pain, Narcotic-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodone hydrochlorideDrug
oxycodone hydrochloride 5 mg tablet under fasted conditions
oxycodone hydrochlorideDrug
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
oxycodone hydrochlorideDrug
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
oxycodone hydrochlorideDrug
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
marketed oxycodone hydrochlorideDrug
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: oxycodone hydrochloride |
| Treatment B | Experimental | Not described Receives: Drug: oxycodone hydrochloride |
| Treatment C | Experimental | Not described Receives: Drug: oxycodone hydrochloride |
| Treatment D | Experimental | Not described Receives: Drug: oxycodone hydrochloride |
| Treatment E | Experimental | Not described Receives: Drug: marketed oxycodone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area under the Concentration-Time Curve (AUC)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Secondary outcomes (11)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Screening up to approximately 3 months
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: Screening up to approximately 3 months
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
Measured: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
Measured: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Heart Rate
Measured: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Respiratory Rate
Measured: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
Measured: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Screening to End-of-Study Assessment in Hematology Parameters
Measured: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Measured: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Measured: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in ECG Measurements
Measured: Screening up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530542
- Sponsor's protocol ID
- K234-10-1001
- Other IDs
- B4501006
- Status last verified
- Feb 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19.
PubMed 22717418
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01530542
- Acronym / sponsor ID
- K234-10-1001
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders
- Keywords
- bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Feb 2012 (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.
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: oxycodone hydrochloride |
| Treatment B | Experimental | Drug: oxycodone hydrochloride |
| Treatment C | Experimental | Drug: oxycodone hydrochloride |
| Treatment D | Experimental | Drug: oxycodone hydrochloride |
| Treatment E | Experimental | Drug: marketed oxycodone hydrochloride |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects between 18 and 55 years of age (inclusive)
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant disease;
- History of obstructive sleep apnea;
- Positive urine drug test.
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 |
|---|---|---|
| oxycodone hydrochlorideoxycodone hydrochloride 5 mg tablet under fasted conditions | Drug | Treatment A |
| oxycodone hydrochloride2 x oxycodone hydrochloride 5 mg tablets under fasted conditions | Drug | Treatment B |
| oxycodone hydrochloride2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions | Drug | Treatment C |
| oxycodone hydrochloride2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions | Drug | Treatment D |
| marketed oxycodone hydrochloride1 x oxycodone hydrochloride 15 mg tablet under fed conditions | Drug | Treatment E |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area under the Concentration-Time Curve (AUC)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
11 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to approximately 3 months
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to approximately 3 months
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Heart Rate
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Respiratory Rate
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Screening to End-of-Study Assessment in Hematology Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in ECG Measurements
Time frame: Screening up to approximately 3 months
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 24 Feb 2012.
- Derived from this study: PubMed 22717418Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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.
Pfizer CT.gov Call Center study director
Pfizer
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 oxycodone hydrochloride and marketed oxycodone hydrochloride in people with Analgesia and Acute Pain, run by Pfizer 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 1 inclusion and 3 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 24 Feb 2012. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.). 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 NCT01530542, which also lists 1 linked publication.
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 24 Feb 2012.