HealthyPhase 1NCT02165930
Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
A Phase 1 study testing Oxycodone and Naltrexone in people with Healthy, run by Pain Therapeutics at 2 sites in United States.
Trial summary
To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxycodone and Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Aug 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- History of moderate alcohol consumption
- Total body weight exceeding 64 kg
Who cannot join
- Evidence or history of clinically significant disease.
- Positive urine drug test
- History of alcoholism or heavy alcohol consumption
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
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 K, single dose, administered with water, under fasting conditions
NaltrexoneDrug
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).
OxycodoneDrug
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
NaltrexoneDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Oxycodone; Drug: Naltrexone |
| Treatment B | Experimental | Not described Receives: Drug: Oxycodone; Drug: Naltrexone |
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)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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 posted18 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2014
- Study completionAug 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
- 17 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
- NCT02165930
- Sponsor's protocol ID
- B4501037
- Status last verified
- Mar 2016
- First submitted
- 10 Jun 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, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
- ClinicalTrials.gov ID
- NCT02165930
- Acronym / sponsor ID
- B4501037
- Conditions
- Healthy
- Keywords
- Bioavailability, oxycodone, ethanol interaction, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jun 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 Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Oxycodone, Drug: Naltrexone |
| Treatment B | Experimental | Drug: Oxycodone, Drug: Naltrexone |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- History of moderate alcohol consumption
- Total body weight exceeding 64 kg
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant disease.
- Positive urine drug test
- History of alcoholism or heavy alcohol consumption
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 K, single dose, administered with water, under fasting conditions | Drug | Treatment A |
| NaltrexoneSingle 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). | Drug | Treatment A |
| OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions | Drug | Treatment B |
| NaltrexoneSingle 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). | Drug | Treatment B |
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
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 Oxycodone and Naltrexone in people with Healthy, run by Pain Therapeutics at 2 sites 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 3 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 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 2 sites 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.