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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
89
0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
Pfizer Investigational Site
Salt Lake City, Utah, United States
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
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
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
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
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
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
High: Area Under Effect Curve (AUE) From 0-1 Hour
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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
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
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
Take Drug Again: Mean Effect (Emean)
Time frame: 12, 24 h post-dose
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
Overall Drug Liking: Mean Effect (Emean)
Time frame: 12, 24 h post-dose
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)
Time frame: pre-dose, 5 min post-dose
Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)
Time frame: pre-dose, 5 min post-dose
Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)
Time frame: pre-dose, 5 min post-dose
Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)
Time frame: pre-dose, 5 min post-dose
Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)
Time frame: pre-dose, 5 min post-dose
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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