HealthyPhase 1NCT01677039
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
A Phase 1 study testing Test formulation administered with water, Test formulation administered with 20% ethanol and Test formulation administered with 40% ethanol in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). 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?
- Test formulation administered with water, Test formulation administered with 20% ethanol and Test formulation administered with 40% ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2012
- 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
- history of clinically significant disease
- history of sleep apnea
- any condition affecting drug absorption
- pregnant or nursing female subjects
- history of allergy or hypersensitivity to either oxycodone or naltrexone
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
- Conditions
- Healthy
- Being tested
- Test formulation administered with water, Test formulation administered with 20% ethanol, Test formulation administered with 40% ethanol
- Keywords
- Bioavailability, oxycodone, ethanol interaction, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulation administered with waterDrug
Also called ALO-02 20 mg
single dose of 20 mg of test formulation with 240 mL of water
Test formulation administered with 20% ethanolDrug
Also called ALO-02 20 mg
single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
Test formulation administered with 40% ethanolDrug
Also called ALO-02 20 mg
single dose of 20 mg of test formulation with 240 mL of 40% ethanol
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Not described Receives: Drug: Test formulation administered with water |
| Treatment B | Experimental | Not described Receives: Drug: Test formulation administered with 20% ethanol |
| Treatment C | Experimental | Not described Receives: Drug: Test formulation administered with 40% ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed oxycodone concentration in plasma (Cmax)
Measured: hours after dosing
Area under the oxycodone concentration versus time curve (AUC)
Measured: hours after dosing
Secondary outcomes (3)
Time-to-peak concentration (Tmax)
Measured: hours after dosing
half-life of drug
Measured: hours after dosing
Vital signs and adverse events
Measured: hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
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 HealthyStudies 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
- 19 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
- NCT01677039
- Sponsor's protocol ID
- B4531004
- Status last verified
- Dec 2012
- First submitted
- 29 Aug 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.
PubMed 25724154
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01677039
- Acronym / sponsor ID
- B4531004
- Conditions
- Healthy
- Keywords
- Bioavailability, oxycodone, ethanol interaction, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Aug 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.
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Test formulation administered with water |
| Treatment B | Experimental | Drug: Test formulation administered with 20% ethanol |
| Treatment C | Experimental | Drug: Test formulation administered with 40% ethanol |
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 (5 listed)
- history of clinically significant disease
- history of sleep apnea
- any condition affecting drug absorption
- pregnant or nursing female subjects
- history of allergy or hypersensitivity to either oxycodone or naltrexone
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 |
|---|---|---|
| Test formulation administered with waterAlso: ALO-02 20 mgsingle dose of 20 mg of test formulation with 240 mL of water | Drug | Treatment A |
| Test formulation administered with 20% ethanolAlso: ALO-02 20 mgsingle dose of 20 mg of test formulation with 240 mL of 20% ethanol in water | Drug | Treatment B |
| Test formulation administered with 40% ethanolAlso: ALO-02 20 mgsingle dose of 20 mg of test formulation with 240 mL of 40% ethanol | Drug | Treatment C |
Primary outcome
Maximum observed oxycodone concentration in plasma (Cmax)
Time frame: hours after dosing
Area under the oxycodone concentration versus time curve (AUC)
Time frame: hours after dosing
3 secondary outcomes
Time-to-peak concentration (Tmax)
Time frame: hours after dosing
half-life of drug
Time frame: hours after dosing
Vital signs and adverse events
Time frame: hours after dosing
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 11 Dec 2012.
- Derived from this study: PubMed 25724154Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.
- 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 Test formulation administered with water, Test formulation administered with 20% ethanol and Test formulation administered with 40% ethanol in people with Healthy, 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 3 inclusion and 5 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 11 Dec 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 oxycodone concentration in plasma (Cmax) (time frame: hours after dosing). 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?
On the ClinicalTrials.gov record for NCT01677039, 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 11 Dec 2012.