HealthyPhase 1/2NCT00751478
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
A Phase 1/2 study testing ALO-01 and MSIR in people with Healthy, run by Pfizer at 1 site in Canada.
Trial summary
The purpose of the study is to determine the relative pharmacodynamic effects and safety of crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole ALO-01 compared to MSIR, and from crushed… 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-01 and MSIR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to May 2007
- Phase
- Phase 1/2
- 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
- Male or female subjects 18 to 55 years of age, inclusive.
- Subjects had to be opioid users who were not currently physically dependent on opioids (based on DSM-IV criteria) but had experience in the use of opioids for non-therapeutic purposes (i.e. for psychoactive effects) on at least 10 occasions within last year and at least once in the 12 weeks prior to the screening session.
- Subjects had to be healthy as indicated by medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG performed at the screening session.
- Subjects had to consent to use two medically acceptable methods of contraception throughout the entire study period, including washout periods, and for females until one week after the study was completed.
- Female subjects had to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the qualifying session and each treatment session, and not be lactating.
- Subject was willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for any outpatient visits.
Show all 10Show fewer
- Subjects with a positive urine drug screen for opiates, amphetamines, cocaine and benzodiazepines at screening could enroll, provided they tested negative for the substances at the qualifying and each treatment session and had no clinically observed signs or symptoms of drug withdrawal.
- Subjects with a positive urine screen of tetrahydrocannabinol (THC) at screening could be enrolled, provided the THC levels were stable or decreasing on subsequent drug screens (prior to the qualifying and each treatment session).
- Subjects with body mass index (BMI) within the range 21-31 kg/m2 and weight greater than 55 kg, inclusive.
- Subjects had to voluntarily consent to participate in this study, provide their written informed consent prior to commencement of any study-specific procedures and understand that they were free to withdraw from the study at any time.
Who cannot join
- Subjects excluded from the study were those:
- With a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- With a history of clinically significant brain conditions (e.g., neoplasms, cerebrovascular disease, history of stroke, syncope, infectious disease or significant head trauma) or currently were being treated with medications or treatment regimens that lower seizure threshold.
- With a history or presence of drug or alcohol dependence excluding nicotine and caffeine. This included subjects who had ever been in a drug rehabilitation program.
- Who had a current psychiatric illness, except nicotine dependence. Subjects with a past history of psychiatric illness could be excluded at the discretion of the Investigator or designee.
- Who had a history of chronic obstructive pulmonary disease or any other lung disease (e.g., asthma) that could cause CO2 retention.
Show all 19Show fewer
- Who had a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
- Who had a history of allergic or adverse response to the study drugs or related drugs.
- Who had started a significantly restrictive diet during the four weeks preceding the first dose of study medication (qualifying session).
- Who had donated blood or plasma within 30 days prior to the first dose of study medication.
- Male subjects with hemoglobin less than 125 g/L and female subjects with hemoglobin less than 115 g/L.
- Who had participated in another clinical trial within 30 days prior to the first dose of study medication (qualifying session).
- Who had used any over-the-counter (OTC) medication, including vitamins and natural health products, within seven days prior to the first dose of study medication (qualifying session) without evaluation and approval by the study investigator.
- Who had used any prescription medication, except hormonal contraceptives or hormonal replacement therapy, within seven days prior to the first dose of study medication (qualifying session) without evaluation and approval by the study investigator.
- Who had a history of glaucoma or any other pupil abnormalities that in the opinion of the qualified investigator or designee could interfere with the ability to perform pupillometry.
- Who were not able to abstain from nicotine smoking while being in the clinical unit
- Who had had a positive test for or been treated for hepatitis B, hepatitis C or HIV.
- Who had current or pending legal charges.
- Who, in the opinion of the investigator, was not considered to be suitable and was unlikely to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Triple-Dummy, Single-Dose, Four-Way Crossover Study to Determine the Relative Bioavailability, Pharmacodynamic Effects, and Safety of Equivalent Doses of Whole and Crushed ALO-01 Versus Morphine IR in Opioid Experienced, Non-Dependent Subjects
The purpose of the study is to determine the relative pharmacodynamic effects and safety of crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole ALO-01 compared to MSIR, and from crushed ALO-01 to whole ALO-01; and to determine the relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole ALO-01.
- Conditions
- Healthy
- Being tested
- ALO-01, MSIR, Placebo
- Keywords
- ALO-01, morphine, Determination of the relative pharmacodynamic effects, (including drug-liking), pharmacokinetics, and safety of, ALO-01 when administered whole or crushed and compared to, equivalent doses of immediate release morphine and placebo
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALO-01Drug
Also called Morphine sulfate extended-release with sequestered naltrexone hydrochloride capsules
ALO-01 capsules
MSIRDrug
immediate release morphine sulfate
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 2 Placebo capsules (whole) + ALO-01 2 x 60 mg capsules (crushed) in apple juice + apple juice (MSIR placebo) Receives: Drug: ALO-01 |
| B | Experimental | 2 x 60 mg ALO-01 (whole) + 2 x placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) Receives: Drug: ALO-01 |
| C | Active comparator | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + 120 mg MSIR in apple juice Receives: Drug: MSIR |
| D | Placebo comparator | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillometry - Minimum Apparent Post-dose Pupil Diameter
Measured: Up to 24 hours post dosing
Pupillometry - Time to Minimum Apparent Post-dose Pupil Diameter
Measured: Up to 24 hours post dosing
VAS-Drug Liking - Peak effect (Emax)
Measured: Up to 24 hours post dosing
VAS-Drug Liking - Time of peak effect (TEmax)
Measured: Up to 24 hours post dosing
Cole/ARCI-Stimulation-Euphoria - Peak effect (Emax)
Measured: Up to 24 hours post dosing
Cole/ARCI-Stimulation-Euphoria - Time of peak effect (TEmax)
Measured: Up to 24 hours post dosing
VAS-High - Peak effect (Emax)
Measured: Up to 24 hours post dosing
VAS-High - Time of peak effect (TEmax)
Measured: Up to 24 hours post dosing
Secondary outcomes (10)
Morphine Cmax
Measured: Up to 24 hours post dosing
Morphine Tmax
Measured: Up to 24 hours post dosing
Morphine AUC (0-8 h)
Measured: 0 - 8 hours post dosing
Morphine AUC (0-last)
Measured: Up to 24 hours post dosing
Morphine AUC (0-inf)
Measured: Up to 24 hours post dosing
Naltrexone Cmax
Measured: Up to 24 hours post dosing
Naltrexone Tmax
Measured: Up to 24 hours post dosing
Naltrexone AUC (0-8 h)
Measured: 0-8 hours post dosing
Naltrexone AUC (0-last)
Measured: Up to 24 hours post dosing
Naltrexone AUC (0-inf)
Measured: Up to 24 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2007
- Study completionMay 2007
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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myroslav Romach, MSC, MD, Principal investigator, DecisionLine Clinical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751478
- Sponsor's protocol ID
- ALO-01-07-205
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2008
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Triple-Dummy, Single-Dose, Four-Way Crossover Study to Determine the Relative Bioavailability, Pharmacodynamic Effects, and Safety of Equivalent Doses of Whole and Crushed ALO-01 Versus Morphine IR in Opioid Experienced, Non-Dependent Subjects
- ClinicalTrials.gov ID
- NCT00751478
- Acronym / sponsor ID
- ALO-01-07-205
- Conditions
- Healthy
- Keywords
- ALO-01, morphine, Determination of the relative pharmacodynamic effects, (including drug-liking), pharmacokinetics, and safety of, ALO-01 when administered whole or crushed and compared to, equivalent doses of immediate release morphine and placebo
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2008 (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 the study is to determine the relative pharmacodynamic effects and safety of crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole ALO-01 compared to MSIR, and from crushed ALO-01 to whole ALO-01; and to determine the relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole ALO-01.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ALO-012 Placebo capsules (whole) + ALO-01 2 x 60 mg capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| B | Experimental | Drug: ALO-012 x 60 mg ALO-01 (whole) + 2 x placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| C | Active comparator | Drug: MSIR2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + 120 mg MSIR in apple juice |
| D | Placebo comparator | Drug: Placebo2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects 18 to 55 years of age, inclusive.
- Subjects had to be opioid users who were not currently physically dependent on opioids (based on DSM-IV criteria) but had experience in the use of opioids for non-therapeutic purposes (i.e. for psychoactive effects) on at least 10 occasions within last year and at least once in the 12 weeks prior to the screening session.
- Subjects had to be healthy as indicated by medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG performed at the screening session.
- Subjects had to consent to use two medically acceptable methods of contraception throughout the entire study period, including washout periods, and for females until one week after the study was completed.
- Female subjects had to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the qualifying session and each treatment session, and not be lactating.
Key exclusion criteria (19 listed)
- With a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- With a history of clinically significant brain conditions (e.g., neoplasms, cerebrovascular disease, history of stroke, syncope, infectious disease or significant head trauma) or currently were being treated with medications or treatment regimens that lower seizure threshold.
- With a history or presence of drug or alcohol dependence excluding nicotine and caffeine. This included subjects who had ever been in a drug rehabilitation program.
- Who had a current psychiatric illness, except nicotine dependence. Subjects with a past history of psychiatric illness could be excluded at the discretion of the Investigator or designee.
- Who had a history of chronic obstructive pulmonary disease or any other lung disease (e.g., asthma) that could cause CO2 retention.
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-01Also: Morphine sulfate extended-release with sequestered naltrexone hydrochloride capsulesALO-01 capsules | Drug | A, B |
| MSIRimmediate release morphine sulfate | Drug | C |
| PlaceboPlacebo | Drug | D |
Primary outcome
Pupillometry - Minimum Apparent Post-dose Pupil Diameter
Time frame: Up to 24 hours post dosing
Pupillometry - Time to Minimum Apparent Post-dose Pupil Diameter
Time frame: Up to 24 hours post dosing
VAS-Drug Liking - Peak effect (Emax)
Time frame: Up to 24 hours post dosing
VAS-Drug Liking - Time of peak effect (TEmax)
Time frame: Up to 24 hours post dosing
Cole/ARCI-Stimulation-Euphoria - Peak effect (Emax)
Time frame: Up to 24 hours post dosing
Cole/ARCI-Stimulation-Euphoria - Time of peak effect (TEmax)
Time frame: Up to 24 hours post dosing
VAS-High - Peak effect (Emax)
Time frame: Up to 24 hours post dosing
VAS-High - Time of peak effect (TEmax)
Time frame: Up to 24 hours post dosing
10 secondary outcomes
Morphine Cmax
Time frame: Up to 24 hours post dosing
Morphine Tmax
Time frame: Up to 24 hours post dosing
Morphine AUC (0-8 h)
Time frame: 0 - 8 hours post dosing
Morphine AUC (0-last)
Time frame: Up to 24 hours post dosing
Morphine AUC (0-inf)
Time frame: Up to 24 hours post dosing
Naltrexone Cmax
Time frame: Up to 24 hours post dosing
Naltrexone Tmax
Time frame: Up to 24 hours post dosing
Naltrexone AUC (0-8 h)
Time frame: 0-8 hours post dosing
Naltrexone AUC (0-last)
Time frame: Up to 24 hours post dosing
Naltrexone AUC (0-inf)
Time frame: Up to 24 hours post 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 16 Sep 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Myroslav Romach, MSC, MD principal investigator
DecisionLine Clinical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALO-01 and MSIR in people with Healthy, run by Pfizer at 1 site in Canada.
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 10 inclusion and 19 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 16 Sep 2013. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pupillometry - Minimum Apparent Post-dose Pupil Diameter (time frame: Up to 24 hours post dosing). The study lists 8 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 16 Sep 2013.