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Trial record 1 of 1 for:    NCT00751478
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Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)

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ClinicalTrials.gov Identifier: NCT00751478
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 12, 2008
Last Update Posted Date September 16, 2013
Study Start Date  ICMJE March 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
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 [ Time Frame: Up to 24 hours post dosing ]
Change History Complete list of historical versions of study NCT00751478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
  • 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 [ Time Frame: Up to 24 hours post dose ]
  • To determine the relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole ALO-01 [ Time Frame: Up to 24 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
Official Title  ICMJE 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
Brief 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ALO-01
    ALO-01 capsules
    Other Name: Morphine sulfate extended-release with sequestered naltrexone hydrochloride capsules
  • Drug: MSIR
    immediate release morphine sulfate
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: A
    2 Placebo capsules (whole) + ALO-01 2 x 60 mg capsules (crushed) in apple juice + apple juice (MSIR placebo)
    Intervention: Drug: ALO-01
  • Experimental: B
    2 x 60 mg ALO-01 (whole) + 2 x placebo capsules (crushed) in apple juice + apple juice (MSIR placebo)
    Intervention: Drug: ALO-01
  • Active Comparator: C
    2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + 120 mg MSIR in apple juice
    Intervention: Drug: MSIR
  • Placebo Comparator: D
    2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + apple juice (MSIR placebo)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2008)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751478
Other Study ID Numbers  ICMJE ALO-01-07-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myroslav Romach, MSC, MD DecisionLine Clinical research
PRS Account Pfizer
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP