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CompletedNCT01825447Updated Oct 8, 2013

A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

A Phase 1 interventional study of Placebo and Oxycodone + Naltrexone in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-08.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

02

Conditions studied

  • Healthy

Keywords

  • abuse potential
  • abuse liability
  • drug liking
  • oxycodone
  • naltrexone
  • intravenous
  • pharmacodynamic
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects
  • Non-dependent, recreational opioid users
  • Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence
  • Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
  • History of sleep apnea.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
89 participants (actual)

Study arms

  • Placebo comparator
    Treatment A

    Drug: Placebo

  • Experimental
    Treatment B

    Drug: Oxycodone + Naltrexone

  • Active comparator
    Treatment C

    Drug: Oxycodone

Interventions

  • DrugPlacebo

    0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.

  • DrugOxycodone + Naltrexone

    Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.

  • DrugOxycodone

    Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

06

What researchers measure

Primary outcomes

  1. Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

    Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  2. Drug Liking: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  3. High: Area Under Effect Curve (AUE) From 0-2 Hours

    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  4. High: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Secondary outcomes

  1. Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour

    Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  2. Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  3. High: Area Under Effect Curve (AUE) From 0-1 Hour

    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  4. High: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  5. Take Drug Again: Peak Effect (Emax)

    Take Drug Again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =

    Time frame: 12, 24 h post-dose

  6. Take Drug Again: Mean Effect (Emean)

    Time frame: 12, 24 h post-dose

  7. Overall Drug Liking: Peak Effect (Emax)

    Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =

    Time frame: 12, 24 h post-dose

  8. Overall Drug Liking: Mean Effect (Emean)

    Time frame: 12, 24 h post-dose

  9. Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  10. Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  11. Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  12. Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  13. Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h

  14. Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  15. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  16. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h

  17. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  18. Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour

    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  19. Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  20. Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  21. Nausea: Area Under Effect Curve (AUE) From 0-1 Hour

    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  22. Nausea: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  23. Nausea: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  24. Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour

    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  25. Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  26. Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  27. Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour

    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  28. Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  29. Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  30. Any Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  31. Good Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  32. Bad Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  33. Feel Sick: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  34. Nausea: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  35. Sleepy: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  36. Dizzy: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  37. Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour

    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

  38. Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  39. Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  40. Pupillometry: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  41. Pupillometry: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  42. Drug Liking: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  43. High: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  44. Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  45. Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  46. Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  47. Sleepy: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  48. Dizzy: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  49. Nausea: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  50. Feel Sick: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  51. Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  52. Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  53. Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  54. Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  55. Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  56. Plasma Decay Half-Life (t1/2) of Oxycodone

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  57. Plasma Decay Half-Life (t1/2) of Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  58. Plasma Decay Half-Life (t1/2) of Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  59. Plasma Decay Half-Life (t1/2) of Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  60. Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  61. Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)

    AUC is a measure of the plasma concentration of the drug over time.

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  62. Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  63. Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  64. Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  65. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  66. Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  67. Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  68. Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  69. Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  70. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  71. Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  72. Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  73. Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  74. Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  75. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  76. Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  77. Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  78. Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  79. Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  80. Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  81. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  82. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  83. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  84. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  85. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  86. Systemic Clearance (Cl) of Oxycodone

    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  87. Systemic Clearance (Cl) of Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  88. Systemic Clearance (Cl) of Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  89. Systemic Clearance (Cl) of Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  90. Systemic Clearance (Cl) of 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  91. Volume of Distribution at Steady State (Vss) for Oxycodone

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  92. Volume of Distribution at Steady State (Vss) for Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  93. Volume of Distribution at Steady State (Vss) for Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  94. Volume of Distribution at Steady State (Vss) for Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  95. Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

07

Study locations

1 site
  • Pfizer Investigational Site
    Salt Lake City, Utah 84106, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01825447
Lead sponsor
Pfizer
Collaborators
Lifetree Clinical Research Center, Salt Lake City, Utah
Responsible party
Sponsor
First posted
Apr 5, 2013
Start date
Jul 2013
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Oct 8, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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