HealthyPhase 1NCT01456507
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
A Phase 1 study testing ALO-02 (Oxycodone Naltrexone) in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg. 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?
- ALO-02 (Oxycodone Naltrexone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
Who cannot join
- Evidence or history of clinically significant diseases
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 in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Read the detailed description
Bioavailability
- Conditions
- Healthy
- Being tested
- ALO-02 (Oxycodone Naltrexone)
- Keywords
- Food effect, bioavailability, oxycodone, sequestered Naltrexone, management of moderate to severe pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALO-02 (Oxycodone Naltrexone)Drug
single dose of ALO-02 capsule under fasting condition
ALO-02 (Oxycodone Naltrexone)Drug
single dose of ALO-02 capsule under fed condition
ALO-02 (Oxycodone Naltrexone)Drug
ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions. Receives: Drug: ALO-02 (Oxycodone Naltrexone) |
| B | Experimental | 1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast). Receives: Drug: ALO-02 (Oxycodone Naltrexone) |
| C | Experimental | 1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions. Receives: Drug: ALO-02 (Oxycodone Naltrexone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) to time infinity (inf) of oxycodone
Measured: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone
Measured: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Maximum Plasma Concentration (Cmax) of oxycodone
Measured: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Secondary outcomes (3)
C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.
Measured: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit
Measured: predose, 1,2,4,8,12,24,48,120 hours post-dose
Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.
Measured: over 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01456507
- Sponsor's protocol ID
- B4531003
- Status last verified
- Sep 2018
- First submitted
- 13 Oct 2011
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. 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 in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
- ClinicalTrials.gov ID
- NCT01456507
- Acronym / sponsor ID
- B4531003
- Conditions
- Healthy
- Keywords
- Food effect, bioavailability, oxycodone, sequestered Naltrexone, management of moderate to severe pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Oct 2011 (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 purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Detailed description
Bioavailability
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ALO-02 (Oxycodone Naltrexone)1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions. |
| B | Experimental | Drug: ALO-02 (Oxycodone Naltrexone)1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast). |
| C | Experimental | Drug: ALO-02 (Oxycodone Naltrexone)1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions. |
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 the ages of 18 and 55 years, inclusive
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant diseases
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 |
|---|---|---|
| ALO-02 (Oxycodone Naltrexone)single dose of ALO-02 capsule under fasting condition | Drug | A |
| ALO-02 (Oxycodone Naltrexone)single dose of ALO-02 capsule under fed condition | Drug | B |
| ALO-02 (Oxycodone Naltrexone)ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions. | Drug | C |
Primary outcome
Area Under the Curve (AUC) to time infinity (inf) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Maximum Plasma Concentration (Cmax) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
3 secondary outcomes
C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit
Time frame: predose, 1,2,4,8,12,24,48,120 hours post-dose
Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.
Time frame: over 120 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 28 Sep 2018.
- 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 ALO-02 (Oxycodone Naltrexone) 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 1 inclusion and 1 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 28 Sep 2018. 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 (AUC) to time infinity (inf) of oxycodone (time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose). The study lists 3 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 28 Sep 2018.