HealthyPhase 1NCT02059915
Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
A Phase 1 study testing Oxycodone in people with Healthy, run by Pain Therapeutics at 1 site in United States.
Trial summary
To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2014
- 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 and/or female subjects between 18 and 55 years of age
Who cannot join
- Evidence or history of clinically significant disease.
- Positive urine drug test
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers
To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers
- Conditions
- Healthy
- Being tested
- Oxycodone
- Keywords
- pharmacokinetics, bioequivalence, bioavailability, oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions
OxycodoneDrug
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
OxycodoneDrug
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
OxycodoneDrug
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Receives: Drug: Oxycodone |
| Treatment B | Experimental | Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Receives: Drug: Oxycodone |
| Treatment C | Experimental | Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Receives: Drug: Oxycodone |
| Treatment D | Experimental | Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Maximum Observed Plasma Concentration (Cmax)
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Secondary outcomes (4)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Concentration at time 24 hours (C24)
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Plasma Decay Half-Life (t1/2)
Measured: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- 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
- NCT02059915
- Sponsor's protocol ID
- B4501015
- Status last verified
- Aug 2014
- First submitted
- 7 Feb 2014
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02059915
- Acronym / sponsor ID
- B4501015
- Conditions
- Healthy
- Keywords
- pharmacokinetics, bioequivalence, bioavailability, oxycodone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Feb 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 Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: OxycodoneSingle dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
| Treatment B | Experimental | Drug: OxycodoneSingle dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
| Treatment C | Experimental | Drug: OxycodoneSingle dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
| Treatment D | Experimental | Drug: OxycodoneSingle dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects between 18 and 55 years of age
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant disease.
- 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 |
|---|---|---|
| OxycodoneOne capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions | Drug | Treatment A |
| OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions | Drug | Treatment B |
| OxycodoneOne capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions | Drug | Treatment C |
| OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions | Drug | Treatment D |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
4 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Concentration at time 24 hours (C24)
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Plasma Decay Half-Life (t1/2)
Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
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 4 Apr 2016.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
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 in people with Healthy, run by Pain Therapeutics 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 2 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 4 Apr 2016. 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 Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] (time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48). 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 4 Apr 2016.