Healthy
Conditions
Keywords
Relative abuse potential study, Chronic pain, oxycodone, naltrexone, opioid-related disorders, drug abusers
Brief summary
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
Detailed description
Abuse Liability Study
Interventions
DRUGALO-02 weight-matched placebo
crushed sugar spheres (powder) x 1 dose
DRUGcrushed ALO-02 30 mg/3.6 mg
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
DRUGoxycodone weight-matched placebo
crushed lactose tablets (powder) x 1 dose
DRUGcrushed oxycodone IR 30 mg
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
Sponsors
Syneos Health
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects * Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit). * Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Liking: Peak Effect (Emax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | 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 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score. |
| High: Area Under Effect Curve (AUE) From 0-2 Hour | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. |
| High: Peak Effect (Emax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose | 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 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Dose (Drug Powder) Insufflated | Intervention period: 0 Hour post-dose | The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period. |
| Any Drug Effects: Peak Effect (Emax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Good Drug Effects: Peak Effect (Emax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Bad Drug Effects: Peak Effect (Emax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Feel Sick: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Nausea: Peak Effect (Emax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Nausea: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Sleepy: Peak Effect (Emax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Sleepy: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Dizzy: Peak Effect (Emax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Dizzy: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| Pupillometry: Peak Effect (Emax) | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score. |
| Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). |
| Pupillometry: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score. |
| Take Drug Again: Peak Effect (Emax) | Intervention period: 12, 24 hours post-dose | 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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score. |
| Take Drug Again: Mean Effect (Emean) | Intervention period: 12, 24 hours post-dose | 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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emean = Average observed score. |
| Feel Sick: Peak Effect (Emax) | Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. |
| Take Drug Again Effect at Hours 12 and 24 | Intervention period: 12, 24 hours post-dose | 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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). |
| Overall Drug Liking: Peak Effect (Emax) | Intervention period: 12, 24 hours post-dose | 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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score. |
| Overall Drug Liking: Mean Effect (Emean) | Intervention period: 12, 24 hours post-dose | 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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score. |
| Overall Drug Liking Effect at Hours 12 and 24 | Intervention period: 12, 24 hours post-dose | 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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose | Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). |
| Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose | Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). TEmax = Time to maximum observed score. |
| Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. |
| Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
| Number of Participants With Clinically Significant Change in Vital Sign Examinations | Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal | Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion. |
| Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion. |
| Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours | Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported. |
| Drug Liking: Time to Maximum (Peak) Effect (TEmax) | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | 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 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score. |
| Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose | Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). Emax = Maximum observed score. |
| Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | 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 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). |
| High: Time to Maximum (Peak) Effect (TEmax) | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. |
| High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). |
Countries
Canada
Participant flow
Recruitment details
Recreational opioid users who had experience with intranasal administration of opiates and were not dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, were recruited in this study.
Pre-assignment details
After successful naloxone challenge test, all participants underwent training sessions involving complete pharmacodynamics test battery before the drug discrimination phase, to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Included all participants enrolled in the study. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Drug Discrimination Phase: Day 1 | Adverse Event | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| Drug Discrimination Phase: Day 2 | Did Not Meet Entrance Criteria | 0 | 2 | 7 | 0 | 0 | 0 | 0 |
| Drug Discrimination Phase: Day 2 | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Phase: Washout Period 1 | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Phase: Washout Period 2 | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment Phase: Washout Period 3 | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 45 | 43 / 45 | 3 / 45 | 4 / 29 | 16 / 30 | 7 / 30 | 32 / 32 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 | 0 / 42 | 0 / 29 | 0 / 30 | 0 / 30 | 0 / 32 |
Outcome results
Primary
Drug Liking: Area Under Effect Curve (AUE) From 0-2 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 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | 98.518 hours*mm | Standard Deviation 6.7606 |
| ALO-02 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | 105.286 hours*mm | Standard Deviation 21.3736 |
| Placebo Lactose Tablet | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | 100.241 hours*mm | Standard Deviation 3.3227 |
| Oxycodone 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | 159.580 hours*mm | Standard Deviation 32.1643 |
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.217695% CI: [-4, 17.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [-65.1, -44.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.350295% CI: [-5.6, 15.5]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.762495% CI: [-12.1, 8.9]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [49, 70.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [50.6, 71.7]Mixed Models Analysis
Primary
Drug Liking: Peak Effect (Emax)
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 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Drug Liking: Peak Effect (Emax) | 50.9 mm | Standard Deviation 1.18 |
| ALO-02 30 mg | Drug Liking: Peak Effect (Emax) | 60.5 mm | Standard Deviation 12.05 |
| Placebo Lactose Tablet | Drug Liking: Peak Effect (Emax) | 51.3 mm | Standard Deviation 3.32 |
| Oxycodone 30 mg | Drug Liking: Peak Effect (Emax) | 92.8 mm | Standard Deviation 11.98 |
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.000195% CI: [4.8, 14.2]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [-37, -27.6]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.000295% CI: [4.5, 13.8]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.880695% CI: [-5, 4.3]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [36.8, 46.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [37.1, 46.4]Mixed Models Analysis
Primary
High: Area Under Effect Curve (AUE) From 0-2 Hour
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | High: Area Under Effect Curve (AUE) From 0-2 Hour | 0.871 hours*mm | Standard Deviation 3.5082 |
| ALO-02 30 mg | High: Area Under Effect Curve (AUE) From 0-2 Hour | 27.750 hours*mm | Standard Deviation 39.7213 |
| Placebo Lactose Tablet | High: Area Under Effect Curve (AUE) From 0-2 Hour | 4.768 hours*mm | Standard Deviation 20.0468 |
| Oxycodone 30 mg | High: Area Under Effect Curve (AUE) From 0-2 Hour | 135.670 hours*mm | Standard Deviation 43.0513 |
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.001595% CI: [10.6, 43.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [-125.7, -93]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.010995% CI: [5.1, 37.8]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.511795% CI: [-21.8, 10.9]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [114.5, 147]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [119.8, 152.5]Mixed Models Analysis
Primary
High: Peak Effect (Emax)
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | High: Peak Effect (Emax) | 2.2 mm | Standard Deviation 10.01 |
| ALO-02 30 mg | High: Peak Effect (Emax) | 26.6 mm | Standard Deviation 28.44 |
| Placebo Lactose Tablet | High: Peak Effect (Emax) | 6.0 mm | Standard Deviation 21.84 |
| Oxycodone 30 mg | High: Peak Effect (Emax) | 85.8 mm | Standard Deviation 24.34 |
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [13.8, 35.3]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [-72.6, -50.9]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.001295% CI: [7.4, 29.1]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: 0.250795% CI: [-17.2, 4.5]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [69.2, 90.7]Mixed Models Analysis
Comparison: Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.p-value: <0.000195% CI: [75.4, 97.1]Mixed Models Analysis
Secondary
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.295 hours*mm | Standard Deviation 1.0179 |
| Placebo Sugar Spheres | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.429 hours*mm | Standard Deviation 1.5517 |
| Placebo Sugar Spheres | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 0.830 hours*mm | Standard Deviation 2.4083 |
| Placebo Sugar Spheres | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1.045 hours*mm | Standard Deviation 2.5917 |
| ALO-02 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 38.290 hours*mm | Standard Deviation 43.2746 |
| ALO-02 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 82.371 hours*mm | Standard Deviation 117.8336 |
| ALO-02 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 96.013 hours*mm | Standard Deviation 138.686 |
| ALO-02 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 18.647 hours*mm | Standard Deviation 21.1164 |
| Placebo Lactose Tablet | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 12.513 hours*mm | Standard Deviation 54.8407 |
| Placebo Lactose Tablet | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 3.701 hours*mm | Standard Deviation 16.0503 |
| Placebo Lactose Tablet | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 12.585 hours*mm | Standard Deviation 54.8265 |
| Placebo Lactose Tablet | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 1.692 hours*mm | Standard Deviation 7.6048 |
| Oxycodone 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 399.719 hours*mm | Standard Deviation 311.1514 |
| Oxycodone 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 138.888 hours*mm | Standard Deviation 48.0836 |
| Oxycodone 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 69.692 hours*mm | Standard Deviation 21.7465 |
| Oxycodone 30 mg | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 329.004 hours*mm | Standard Deviation 197.0154 |
Secondary
Any Drug Effects: Peak Effect (Emax)
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Any Drug Effects: Peak Effect (Emax) | 0.6 mm | Standard Deviation 1.42 |
| ALO-02 30 mg | Any Drug Effects: Peak Effect (Emax) | 35.5 mm | Standard Deviation 31.81 |
| Placebo Lactose Tablet | Any Drug Effects: Peak Effect (Emax) | 6.2 mm | Standard Deviation 17.51 |
| Oxycodone 30 mg | Any Drug Effects: Peak Effect (Emax) | 88.6 mm | Standard Deviation 21.28 |
Secondary
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.517 hours |
| Placebo Lactose Tablet | Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
Secondary
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.045 hours*mm | Standard Deviation 0.1674 |
| Placebo Sugar Spheres | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.116 hours*mm | Standard Deviation 0.4053 |
| Placebo Sugar Spheres | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 0.482 hours*mm | Standard Deviation 1.5766 |
| Placebo Sugar Spheres | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 6.696 hours*mm | Standard Deviation 32.9731 |
| ALO-02 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 6.920 hours*mm | Standard Deviation 12.0601 |
| ALO-02 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 15.000 hours*mm | Standard Deviation 31.8735 |
| ALO-02 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 19.214 hours*mm | Standard Deviation 45.0219 |
| ALO-02 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 3.911 hours*mm | Standard Deviation 7.8416 |
| Placebo Lactose Tablet | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 5.719 hours*mm | Standard Deviation 20.3316 |
| Placebo Lactose Tablet | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.701 hours*mm | Standard Deviation 3.612 |
| Placebo Lactose Tablet | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 6.004 hours*mm | Standard Deviation 20.3044 |
| Placebo Lactose Tablet | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.246 hours*mm | Standard Deviation 1.205 |
| Oxycodone 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 71.375 hours*mm | Standard Deviation 192.392 |
| Oxycodone 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 10.107 hours*mm | Standard Deviation 21.5289 |
| Oxycodone 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 4.080 hours*mm | Standard Deviation 9.9234 |
| Oxycodone 30 mg | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 43.232 hours*mm | Standard Deviation 87.5335 |
Secondary
Bad Drug Effects: Peak Effect (Emax)
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Bad Drug Effects: Peak Effect (Emax) | 1.4 mm | Standard Deviation 5.49 |
| ALO-02 30 mg | Bad Drug Effects: Peak Effect (Emax) | 13.0 mm | Standard Deviation 24.52 |
| Placebo Lactose Tablet | Bad Drug Effects: Peak Effect (Emax) | 5.6 mm | Standard Deviation 15.92 |
| Oxycodone 30 mg | Bad Drug Effects: Peak Effect (Emax) | 18.5 mm | Standard Deviation 26.24 |
Secondary
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| Placebo Lactose Tablet | Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.642 hours |
Secondary
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.036 hours*mm | Standard Deviation 0.189 |
| Placebo Sugar Spheres | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.482 hours*mm | Standard Deviation 2.3628 |
| Placebo Sugar Spheres | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 3.286 hours*mm | Standard Deviation 10.6279 |
| Placebo Sugar Spheres | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 7.143 hours*mm | Standard Deviation 28.6404 |
| ALO-02 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 5.134 hours*mm | Standard Deviation 14.4253 |
| ALO-02 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 8.482 hours*mm | Standard Deviation 20.2822 |
| ALO-02 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 11.768 hours*mm | Standard Deviation 29.2486 |
| ALO-02 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 1.161 hours*mm | Standard Deviation 2.7284 |
| Placebo Lactose Tablet | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 4.938 hours*mm | Standard Deviation 22.2685 |
| Placebo Lactose Tablet | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 1.259 hours*mm | Standard Deviation 4.6194 |
| Placebo Lactose Tablet | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 5.152 hours*mm | Standard Deviation 22.2481 |
| Placebo Lactose Tablet | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.795 hours*mm | Standard Deviation 3.132 |
| Oxycodone 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 57.469 hours*mm | Standard Deviation 119.5335 |
| Oxycodone 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 17.737 hours*mm | Standard Deviation 28.2806 |
| Oxycodone 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 9.192 hours*mm | Standard Deviation 14.5426 |
| Oxycodone 30 mg | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 48.826 hours*mm | Standard Deviation 93.0141 |
Secondary
Dizzy: Peak Effect (Emax)
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Dizzy: Peak Effect (Emax) | 4.4 mm | Standard Deviation 13.34 |
| ALO-02 30 mg | Dizzy: Peak Effect (Emax) | 7.4 mm | Standard Deviation 15.74 |
| Placebo Lactose Tablet | Dizzy: Peak Effect (Emax) | 4.1 mm | Standard Deviation 15.02 |
| Oxycodone 30 mg | Dizzy: Peak Effect (Emax) | 23.5 mm | Standard Deviation 36.62 |
Secondary
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Dizzy: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Dizzy: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| Placebo Lactose Tablet | Dizzy: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Dizzy: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
Secondary
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.036 hours*mm | Standard Deviation 0.1438 |
| Placebo Sugar Spheres | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.545 hours*mm | Standard Deviation 2.3162 |
| Placebo Sugar Spheres | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 1.170 hours*mm | Standard Deviation 4.622 |
| Placebo Sugar Spheres | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1.313 hours*mm | Standard Deviation 4.6839 |
| ALO-02 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 3.424 hours*mm | Standard Deviation 8.1912 |
| ALO-02 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 9.371 hours*mm | Standard Deviation 22.4283 |
| ALO-02 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 10.513 hours*mm | Standard Deviation 24.8145 |
| ALO-02 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 1.549 hours*mm | Standard Deviation 5.3704 |
| Placebo Lactose Tablet | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 4.804 hours*mm | Standard Deviation 19.8483 |
| Placebo Lactose Tablet | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.714 hours*mm | Standard Deviation 3.61 |
| Placebo Lactose Tablet | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 4.875 hours*mm | Standard Deviation 19.8377 |
| Placebo Lactose Tablet | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.232 hours*mm | Standard Deviation 1.2041 |
| Oxycodone 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 42.460 hours*mm | Standard Deviation 144.3171 |
| Oxycodone 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 3.049 hours*mm | Standard Deviation 8.56 |
| Oxycodone 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.442 hours*mm | Standard Deviation 1.5106 |
| Oxycodone 30 mg | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 25.103 hours*mm | Standard Deviation 80.5454 |
Secondary
Feel Sick: Peak Effect (Emax)
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Feel Sick: Peak Effect (Emax) | 2.1 mm | Standard Deviation 9.23 |
| ALO-02 30 mg | Feel Sick: Peak Effect (Emax) | 8.7 mm | Standard Deviation 20.5 |
| Placebo Lactose Tablet | Feel Sick: Peak Effect (Emax) | 3.9 mm | Standard Deviation 13.34 |
| Oxycodone 30 mg | Feel Sick: Peak Effect (Emax) | 4.6 mm | Standard Deviation 21.95 |
Secondary
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Feel Sick: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Feel Sick: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| Placebo Lactose Tablet | Feel Sick: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Feel Sick: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
Secondary
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.804 hours*mm | Standard Deviation 3.3233 |
| Placebo Sugar Spheres | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.902 hours*mm | Standard Deviation 3.5146 |
| Placebo Sugar Spheres | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 2.777 hours*mm | Standard Deviation 10.0925 |
| Placebo Sugar Spheres | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 6.420 hours*mm | Standard Deviation 28.9445 |
| ALO-02 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 26.603 hours*mm | Standard Deviation 39.636 |
| ALO-02 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 58.746 hours*mm | Standard Deviation 110.6803 |
| ALO-02 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 69.246 hours*mm | Standard Deviation 136.6847 |
| ALO-02 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 14.263 hours*mm | Standard Deviation 20.563 |
| Placebo Lactose Tablet | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 14.795 hours*mm | Standard Deviation 62.5301 |
| Placebo Lactose Tablet | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 5.161 hours*mm | Standard Deviation 20.4142 |
| Placebo Lactose Tablet | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 14.795 hours*mm | Standard Deviation 62.5301 |
| Placebo Lactose Tablet | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 2.393 hours*mm | Standard Deviation 9.4972 |
| Oxycodone 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 348.732 hours*mm | Standard Deviation 274.1036 |
| Oxycodone 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 138.679 hours*mm | Standard Deviation 45.7222 |
| Oxycodone 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 69.464 hours*mm | Standard Deviation 21.0703 |
| Oxycodone 30 mg | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 307.589 hours*mm | Standard Deviation 191.3034 |
Secondary
Good Drug Effects: Peak Effect (Emax)
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Good Drug Effects: Peak Effect (Emax) | 4.3 mm | Standard Deviation 13.7 |
| ALO-02 30 mg | Good Drug Effects: Peak Effect (Emax) | 25.6 mm | Standard Deviation 29.6 |
| Placebo Lactose Tablet | Good Drug Effects: Peak Effect (Emax) | 8.4 mm | Standard Deviation 17.98 |
| Oxycodone 30 mg | Good Drug Effects: Peak Effect (Emax) | 87.9 mm | Standard Deviation 21.04 |
Secondary
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.275 hours |
| Placebo Lactose Tablet | Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | 0.400 hours |
Secondary
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.036 hours*mm | Standard Deviation 0.1477 |
| Placebo Sugar Spheres | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.473 hours*mm | Standard Deviation 2.3127 |
| Placebo Sugar Spheres | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 1.000 hours*mm | Standard Deviation 4.6313 |
| Placebo Sugar Spheres | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1.071 hours*mm | Standard Deviation 4.6706 |
| ALO-02 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 5.179 hours*mm | Standard Deviation 11.069 |
| ALO-02 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 9.063 hours*mm | Standard Deviation 17.1052 |
| ALO-02 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 10.848 hours*mm | Standard Deviation 23.1275 |
| ALO-02 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 2.455 hours*mm | Standard Deviation 5.9882 |
| Placebo Lactose Tablet | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 5.353 hours*mm | Standard Deviation 19.5238 |
| Placebo Lactose Tablet | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 0.781 hours*mm | Standard Deviation 3.6209 |
| Placebo Lactose Tablet | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 5.638 hours*mm | Standard Deviation 19.5807 |
| Placebo Lactose Tablet | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.290 hours*mm | Standard Deviation 1.2186 |
| Oxycodone 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 58.759 hours*mm | Standard Deviation 150.9858 |
| Oxycodone 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 7.357 hours*mm | Standard Deviation 15.8889 |
| Oxycodone 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 2.339 hours*mm | Standard Deviation 6.0186 |
| Oxycodone 30 mg | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 46.402 hours*mm | Standard Deviation 114.6615 |
Secondary
Nausea: Peak Effect (Emax)
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Nausea: Peak Effect (Emax) | 1.9 mm | Standard Deviation 9.25 |
| ALO-02 30 mg | Nausea: Peak Effect (Emax) | 9.3 mm | Standard Deviation 20.99 |
| Placebo Lactose Tablet | Nausea: Peak Effect (Emax) | 5.3 mm | Standard Deviation 15.9 |
| Oxycodone 30 mg | Nausea: Peak Effect (Emax) | 12.3 mm | Standard Deviation 29.94 |
Secondary
Nausea: Time to Maximum (Peak) Effect (TEmax)
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Nausea: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Nausea: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| Placebo Lactose Tablet | Nausea: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | Nausea: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
Secondary
Overall Drug Liking Effect at Hours 12 and 24
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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking).
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Overall Drug Liking Effect at Hours 12 and 24 | Hour 12 | 50.3 mm | Standard Deviation 0.53 |
| Placebo Sugar Spheres | Overall Drug Liking Effect at Hours 12 and 24 | Hour 24 | 50.4 mm | Standard Deviation 0.87 |
| ALO-02 30 mg | Overall Drug Liking Effect at Hours 12 and 24 | Hour 24 | 57.6 mm | Standard Deviation 21.34 |
| ALO-02 30 mg | Overall Drug Liking Effect at Hours 12 and 24 | Hour 12 | 56.0 mm | Standard Deviation 20.69 |
| Placebo Lactose Tablet | Overall Drug Liking Effect at Hours 12 and 24 | Hour 12 | 50.5 mm | Standard Deviation 2.28 |
| Placebo Lactose Tablet | Overall Drug Liking Effect at Hours 12 and 24 | Hour 24 | 47.8 mm | Standard Deviation 15.02 |
| Oxycodone 30 mg | Overall Drug Liking Effect at Hours 12 and 24 | Hour 12 | 81.8 mm | Standard Deviation 25.73 |
| Oxycodone 30 mg | Overall Drug Liking Effect at Hours 12 and 24 | Hour 24 | 80.8 mm | Standard Deviation 25.05 |
Secondary
Overall Drug Liking: Mean Effect (Emean)
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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score.
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Overall Drug Liking: Mean Effect (Emean) | 50.32 mm | Standard Deviation 0.641 |
| ALO-02 30 mg | Overall Drug Liking: Mean Effect (Emean) | 56.77 mm | Standard Deviation 20.058 |
| Placebo Lactose Tablet | Overall Drug Liking: Mean Effect (Emean) | 49.16 mm | Standard Deviation 8.131 |
| Oxycodone 30 mg | Overall Drug Liking: Mean Effect (Emean) | 81.25 mm | Standard Deviation 24.081 |
Secondary
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 carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score.
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Overall Drug Liking: Peak Effect (Emax) | 50.5 mm | Standard Deviation 0.84 |
| ALO-02 30 mg | Overall Drug Liking: Peak Effect (Emax) | 59.9 mm | Standard Deviation 21.7 |
| Placebo Lactose Tablet | Overall Drug Liking: Peak Effect (Emax) | 51.5 mm | Standard Deviation 6.59 |
| Oxycodone 30 mg | Overall Drug Liking: Peak Effect (Emax) | 85.1 mm | Standard Deviation 23.84 |
Secondary
Percentage of Dose (Drug Powder) Insufflated
The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.
Time frame: Intervention period: 0 Hour post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Percentage of Dose (Drug Powder) Insufflated | 100.00 percentage of dose | Standard Deviation 0 |
| ALO-02 30 mg | Percentage of Dose (Drug Powder) Insufflated | 99.85 percentage of dose | Standard Deviation 0.84 |
| Placebo Lactose Tablet | Percentage of Dose (Drug Powder) Insufflated | 100.00 percentage of dose | Standard Deviation 0 |
| Oxycodone 30 mg | Percentage of Dose (Drug Powder) Insufflated | 99.37 percentage of dose | Standard Deviation 3.553 |
Secondary
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 5.333 hours*mm | Standard Deviation 0.8204 |
| Placebo Sugar Spheres | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 10.538 hours*mm | Standard Deviation 1.7478 |
| Placebo Sugar Spheres | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 42.623 hours*mm | Standard Deviation 6.9054 |
| Placebo Sugar Spheres | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 130.666 hours*mm | Standard Deviation 18.7096 |
| ALO-02 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 9.114 hours*mm | Standard Deviation 1.6974 |
| ALO-02 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 34.874 hours*mm | Standard Deviation 6.691 |
| ALO-02 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 110.574 hours*mm | Standard Deviation 19.3751 |
| ALO-02 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 4.746 hours*mm | Standard Deviation 0.8291 |
| Placebo Lactose Tablet | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 41.658 hours*mm | Standard Deviation 6.0399 |
| Placebo Lactose Tablet | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 10.162 hours*mm | Standard Deviation 1.5217 |
| Placebo Lactose Tablet | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 128.937 hours*mm | Standard Deviation 16.8685 |
| Placebo Lactose Tablet | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 5.132 hours*mm | Standard Deviation 0.7712 |
| Oxycodone 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 94.012 hours*mm | Standard Deviation 12.6818 |
| Oxycodone 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 5.868 hours*mm | Standard Deviation 0.8325 |
| Oxycodone 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 3.229 hours*mm | Standard Deviation 0.4547 |
| Oxycodone 30 mg | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 23.904 hours*mm | Standard Deviation 3.3208 |
Secondary
Pupillometry: Peak Effect (Emax)
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose PD data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Pupillometry: Peak Effect (Emax) | -0.9 mm | Standard Deviation 0.6 |
| ALO-02 30 mg | Pupillometry: Peak Effect (Emax) | -1.7 mm | Standard Deviation 0.64 |
| Placebo Lactose Tablet | Pupillometry: Peak Effect (Emax) | -0.7 mm | Standard Deviation 0.5 |
| Oxycodone 30 mg | Pupillometry: Peak Effect (Emax) | -2.9 mm | Standard Deviation 0.66 |
Secondary
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | 3.017 hours |
| ALO-02 30 mg | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | 3.017 hours |
| Placebo Lactose Tablet | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | 2.025 hours |
| Oxycodone 30 mg | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | 0.800 hours |
Secondary
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 0.813 hours*mm | Standard Deviation 2.6613 |
| Placebo Sugar Spheres | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 2.580 hours*mm | Standard Deviation 7.9968 |
| Placebo Sugar Spheres | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 19.518 hours*mm | Standard Deviation 52.5582 |
| Placebo Sugar Spheres | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 26.875 hours*mm | Standard Deviation 60.2903 |
| ALO-02 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 187.839 hours*mm | Standard Deviation 217.5872 |
| ALO-02 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 125.196 hours*mm | Standard Deviation 157.0183 |
| ALO-02 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 34.571 hours*mm | Standard Deviation 40.4452 |
| ALO-02 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 8.848 hours*mm | Standard Deviation 13.8043 |
| Placebo Lactose Tablet | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 34.438 hours*mm | Standard Deviation 92.1369 |
| Placebo Lactose Tablet | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 64.795 hours*mm | Standard Deviation 172.8842 |
| Placebo Lactose Tablet | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 8.089 hours*mm | Standard Deviation 19.0222 |
| Placebo Lactose Tablet | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 2.920 hours*mm | Standard Deviation 6.8778 |
| Oxycodone 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-2) | 61.750 hours*mm | Standard Deviation 48.0978 |
| Oxycodone 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 20.464 hours*mm | Standard Deviation 21.9449 |
| Oxycodone 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 496.652 hours*mm | Standard Deviation 424.757 |
| Oxycodone 30 mg | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 304.652 hours*mm | Standard Deviation 210.8188 |
Secondary
Sleepy: Peak Effect (Emax)
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Sleepy: Peak Effect (Emax) | 7.6 mm | Standard Deviation 21.35 |
| ALO-02 30 mg | Sleepy: Peak Effect (Emax) | 35.0 mm | Standard Deviation 36.04 |
| Placebo Lactose Tablet | Sleepy: Peak Effect (Emax) | 11.1 mm | Standard Deviation 28.41 |
| Oxycodone 30 mg | Sleepy: Peak Effect (Emax) | 62.9 mm | Standard Deviation 36.25 |
Secondary
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Sleepy: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| ALO-02 30 mg | Sleepy: Time to Maximum (Peak) Effect (TEmax) | 1.517 hours |
| Placebo Lactose Tablet | Sleepy: Time to Maximum (Peak) Effect (TEmax) | 0.267 hours |
| Oxycodone 30 mg | Sleepy: Time to Maximum (Peak) Effect (TEmax) | 2.517 hours |
Secondary
Take Drug Again Effect at Hours 12 and 24
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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would).
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Take Drug Again Effect at Hours 12 and 24 | Hour 12 | 43.4 mm | Standard Deviation 17.36 |
| Placebo Sugar Spheres | Take Drug Again Effect at Hours 12 and 24 | Hour 24 | 46.1 mm | Standard Deviation 17.4 |
| ALO-02 30 mg | Take Drug Again Effect at Hours 12 and 24 | Hour 24 | 52.8 mm | Standard Deviation 32.62 |
| ALO-02 30 mg | Take Drug Again Effect at Hours 12 and 24 | Hour 12 | 51.5 mm | Standard Deviation 32.74 |
| Placebo Lactose Tablet | Take Drug Again Effect at Hours 12 and 24 | Hour 12 | 43.2 mm | Standard Deviation 18.02 |
| Placebo Lactose Tablet | Take Drug Again Effect at Hours 12 and 24 | Hour 24 | 44.7 mm | Standard Deviation 20.66 |
| Oxycodone 30 mg | Take Drug Again Effect at Hours 12 and 24 | Hour 12 | 87.4 mm | Standard Deviation 26.68 |
| Oxycodone 30 mg | Take Drug Again Effect at Hours 12 and 24 | Hour 24 | 83.3 mm | Standard Deviation 28.34 |
Secondary
Take Drug Again: Mean Effect (Emean)
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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emean = Average observed score.
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Take Drug Again: Mean Effect (Emean) | 44.71 mm | Standard Deviation 14.286 |
| ALO-02 30 mg | Take Drug Again: Mean Effect (Emean) | 52.16 mm | Standard Deviation 30.926 |
| Placebo Lactose Tablet | Take Drug Again: Mean Effect (Emean) | 43.95 mm | Standard Deviation 17.753 |
| Oxycodone 30 mg | Take Drug Again: Mean Effect (Emean) | 85.34 mm | Standard Deviation 26.86 |
Secondary
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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score.
Time frame: Intervention period: 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Sugar Spheres | Take Drug Again: Peak Effect (Emax) | 48.0 mm | Standard Deviation 14.91 |
| ALO-02 30 mg | Take Drug Again: Peak Effect (Emax) | 58.3 mm | Standard Deviation 31.99 |
| Placebo Lactose Tablet | Take Drug Again: Peak Effect (Emax) | 46.6 mm | Standard Deviation 18.75 |
| Oxycodone 30 mg | Take Drug Again: Peak Effect (Emax) | 87.8 mm | Standard Deviation 26.69 |
Other Pre-specified
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | Naltrexone: AUC (0-2) | 5.669 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 1.4721 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | Naltrexone: AUC (0-8) | 10.25 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 3.04 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | Naltrexone: AUC (0-1) | 3.127 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.87457 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol: AUC (0-1) | 1.050 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.56296 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol: AUC (0-2) | 3.862 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 1.7302 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol: AUC (0-8) | 18.78 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 4.8024 |
Other Pre-specified
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-2) | 81.26 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 21.951 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-8) | 1.979 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 1.1448 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-1) | 0.09544 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.07603 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-1) | 5.726 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 4.0397 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-8) | 263.9 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 64.753 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-2) | 26.37 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 15.014 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-2) | 0.4023 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.26464 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-8) | 147.7 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 46.804 |
| Placebo Sugar Spheres | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-1) | 33.59 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 10.01 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-8) | 119.9 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 40.38 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-1) | 59.56 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 14.977 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-2) | 116.3 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 27.449 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone: AUC (0-8) | 328.2 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 73.834 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-1) | 0.1589 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.10643 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-2) | 0.4211 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.25186 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone: AUC (0-8) | 1.856 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 0.99704 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-1) | 6.410 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 2.8655 |
| ALO-02 30 mg | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone: AUC (0-2) | 18.91 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 7.1716 |
Other Pre-specified
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol | Naltrexone (n = 11) | 10.71 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 11.13 |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol (n = 30) | 45.85 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 10.544 |
Other Pre-specified
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 361.2 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 109.33 |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 1, 1) | NA nanogram*hour/milliliter (ng*hr/mL) | — |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 28, 27) | 309.9 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 111.42 |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 447.3 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 123.92 |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 1, 1) | NA nanogram*hour/milliliter (ng*hr/mL) | — |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 28, 27) | 288.8 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 104.33 |
Other Pre-specified
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol | Naltrexone | 11.07 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 3.213 |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol | 37.28 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 9.3207 |
Other Pre-specified
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone | 2.498 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 1.6933 |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone | 353.0 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 103.13 |
| Placebo Sugar Spheres | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone | 280.6 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 95.277 |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone | 248.5 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 84.723 |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone | 435.3 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 112.11 |
| ALO-02 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone | 2.469 nanogram*hour/milliliter (ng*hr/mL) | Standard Deviation 1.8058 |
Other Pre-specified
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 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 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 49.143 hours*mm | Standard Deviation 4.2752 |
| Placebo Sugar Spheres | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1198.955 hours*mm | Standard Deviation 18.421 |
| Placebo Sugar Spheres | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 395.455 hours*mm | Standard Deviation 17.547 |
| ALO-02 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 53.455 hours*mm | Standard Deviation 10.0825 |
| ALO-02 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1223.902 hours*mm | Standard Deviation 72.4917 |
| ALO-02 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 414.045 hours*mm | Standard Deviation 61.643 |
| Placebo Lactose Tablet | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 401.036 hours*mm | Standard Deviation 3.4801 |
| Placebo Lactose Tablet | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 49.884 hours*mm | Standard Deviation 2.7778 |
| Placebo Lactose Tablet | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1202.750 hours*mm | Standard Deviation 6.0623 |
| Oxycodone 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-1) | 81.250 hours*mm | Standard Deviation 13.1291 |
| Oxycodone 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-24) | 1397.911 hours*mm | Standard Deviation 231.233 |
| Oxycodone 30 mg | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour | AUE (0-8) | 540.554 hours*mm | Standard Deviation 122.5684 |
Other Pre-specified
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
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 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | Drug Liking: Time to Maximum (Peak) Effect (TEmax) | 0.383 hours |
| ALO-02 30 mg | Drug Liking: Time to Maximum (Peak) Effect (TEmax) | 0.758 hours |
| Placebo Lactose Tablet | Drug Liking: Time to Maximum (Peak) Effect (TEmax) | 0.500 hours |
| Oxycodone 30 mg | Drug Liking: Time to Maximum (Peak) Effect (TEmax) | 0.383 hours |
Other Pre-specified
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-1) | 0.790 hours*mm | Standard Deviation 3.3474 |
| Placebo Sugar Spheres | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-24) | 1.121 hours*mm | Standard Deviation 4.0488 |
| Placebo Sugar Spheres | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-8) | 1.049 hours*mm | Standard Deviation 3.856 |
| ALO-02 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-1) | 14.250 hours*mm | Standard Deviation 20.4883 |
| ALO-02 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-24) | 75.429 hours*mm | Standard Deviation 136.4319 |
| ALO-02 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-8) | 60.143 hours*mm | Standard Deviation 113.5249 |
| Placebo Lactose Tablet | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-8) | 12.955 hours*mm | Standard Deviation 51.4525 |
| Placebo Lactose Tablet | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-1) | 2.313 hours*mm | Standard Deviation 9.3978 |
| Placebo Lactose Tablet | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-24) | 16.598 hours*mm | Standard Deviation 70.5151 |
| Oxycodone 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-1) | 68.223 hours*mm | Standard Deviation 19.7926 |
| Oxycodone 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-24) | 330.813 hours*mm | Standard Deviation 257.7739 |
| Oxycodone 30 mg | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours | AUE (0-8) | 290.670 hours*mm | Standard Deviation 174.8869 |
Other Pre-specified
High: Time to Maximum (Peak) Effect (TEmax)
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Sugar Spheres | High: Time to Maximum (Peak) Effect (TEmax) | 0.258 hours |
| ALO-02 30 mg | High: Time to Maximum (Peak) Effect (TEmax) | 0.275 hours |
| Placebo Lactose Tablet | High: Time to Maximum (Peak) Effect (TEmax) | 0.250 hours |
| Oxycodone 30 mg | High: Time to Maximum (Peak) Effect (TEmax) | 0.517 hours |
Other Pre-specified
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol | Naltrexone | 4.574 nanogram per milliliter (ng/mL) | Standard Deviation 1.4093 |
| Placebo Sugar Spheres | Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol | 4.085 nanogram per milliliter (ng/mL) | Standard Deviation 1.2948 |
Other Pre-specified
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone
Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the pharmacokinetic (PK) parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone | 57.93 nanogram per milliliter (ng/mL) | Standard Deviation 13.706 |
| Placebo Sugar Spheres | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone | 0.4613 nanogram per milliliter (ng/mL) | Standard Deviation 0.25684 |
| Placebo Sugar Spheres | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone | 29.02 nanogram per milliliter (ng/mL) | Standard Deviation 10.858 |
| ALO-02 30 mg | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone | 82.63 nanogram per milliliter (ng/mL) | Standard Deviation 19.877 |
| ALO-02 30 mg | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone | 0.3441 nanogram per milliliter (ng/mL) | Standard Deviation 0.16644 |
| ALO-02 30 mg | Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone | 18.88 nanogram per milliliter (ng/mL) | Standard Deviation 6.8506 |
Other Pre-specified
Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion.
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Sugar Spheres | Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | 0 participants |
| ALO-02 30 mg | Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | 0 participants |
| Oxycodone 30 mg | Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | 0 participants |
Other Pre-specified
Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.
Time frame: Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Sugar Spheres | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
| ALO-02 30 mg | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
| Oxycodone 30 mg | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
| ALO-02 30 mg | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | 0 participants |
Other Pre-specified
Number of Participants With Clinically Significant Change in Vital Sign Examinations
Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.
Time frame: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Sugar Spheres | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| ALO-02 30 mg | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| Oxycodone 30 mg | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| ALO-02 30 mg | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
| Oxycodone 30 mg | Number of Participants With Clinically Significant Change in Vital Sign Examinations | 0 participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time frame: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Sugar Spheres | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 1 participants |
| Placebo Sugar Spheres | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| ALO-02 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| ALO-02 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 43 participants |
| Placebo Lactose Tablet | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 8 participants |
| Placebo Lactose Tablet | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Oxycodone 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Oxycodone 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 6 participants |
| ALO-02 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 18 participants |
| ALO-02 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo Lactose Tablet | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 10 participants |
| Placebo Lactose Tablet | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Oxycodone 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 32 participants |
| Oxycodone 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
Other Pre-specified
Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol | Naltrexone (n = 30) | 3.577 hours | Standard Deviation 0.71124 |
| Placebo Sugar Spheres | Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol | 6-beta-naltrexol (n = 11) | 9.230 hours | Standard Deviation 0.62809 |
Other Pre-specified
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 4.171 hours | Standard Deviation 0.65437 |
| Placebo Sugar Spheres | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 1, 1) | NA hours | — |
| Placebo Sugar Spheres | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 28, 27) | 7.116 hours | Standard Deviation 1.2582 |
| ALO-02 30 mg | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 4.134 hours | Standard Deviation 0.87884 |
| ALO-02 30 mg | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 1, 1) | NA hours | — |
| ALO-02 30 mg | Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 28, 27) | 7.101 hours | Standard Deviation 0.89387 |
Other Pre-specified
Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-2) | 0.259 units on a scale*hours | Standard Deviation 0.6399 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-1) | 0.009 units on a scale*hours | Standard Deviation 0.0464 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-2) | 0.164 units on a scale*hours | Standard Deviation 0.4147 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-2) | 0.000 units on a scale*hours | Standard Deviation 0 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-2) | 0.009 units on a scale*hours | Standard Deviation 0.0464 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-2) | 0.086 units on a scale*hours | Standard Deviation 0.3342 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-1) | 0.129 units on a scale*hours | Standard Deviation 0.3125 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-1) | 0.000 units on a scale*hours | Standard Deviation 0 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-1) | 0.172 units on a scale*hours | Standard Deviation 0.4111 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-1) | 0.069 units on a scale*hours | Standard Deviation 0.2468 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-1) | 0.083 units on a scale*hours | Standard Deviation 0.3432 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-2) | 0.108 units on a scale*hours | Standard Deviation 0.4437 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-1) | 0.175 units on a scale*hours | Standard Deviation 0.3664 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-2) | 0.183 units on a scale*hours | Standard Deviation 0.552 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-1) | 0.025 units on a scale*hours | Standard Deviation 0.0951 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-1) | 0.033 units on a scale*hours | Standard Deviation 0.1428 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-1) | 0.117 units on a scale*hours | Standard Deviation 0.3182 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-2) | 0.025 units on a scale*hours | Standard Deviation 0.0951 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-2) | 0.250 units on a scale*hours | Standard Deviation 0.5835 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-2) | 0.050 units on a scale*hours | Standard Deviation 0.2312 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-2) | 0.088 units on a scale*hours | Standard Deviation 0.2503 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-1) | 0.200 units on a scale*hours | Standard Deviation 0.3934 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-2) | 0.033 units on a scale*hours | Standard Deviation 0.1035 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-2) | 0.242 units on a scale*hours | Standard Deviation 0.4956 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-1) | 0.088 units on a scale*hours | Standard Deviation 0.2503 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-2) | 0.050 units on a scale*hours | Standard Deviation 0.1416 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-1) | 0.038 units on a scale*hours | Standard Deviation 0.1046 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-1) | 0.033 units on a scale*hours | Standard Deviation 0.1035 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-2) | 0.146 units on a scale*hours | Standard Deviation 0.4678 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-1) | 0.042 units on a scale*hours | Standard Deviation 0.1367 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-2) | 0.484 units on a scale*hours | Standard Deviation 0.7853 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-1) | 0.184 units on a scale*hours | Standard Deviation 0.3062 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Burning: AUE (0-2) | 0.270 units on a scale*hours | Standard Deviation 0.6214 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-1) | 0.293 units on a scale*hours | Standard Deviation 0.4586 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Need to Blow Nose: AUE (0-2) | 0.504 units on a scale*hours | Standard Deviation 0.8616 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-1) | 0.184 units on a scale*hours | Standard Deviation 0.3521 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Runny Nose/ Nasal Discharge: AUE (0-2) | 0.301 units on a scale*hours | Standard Deviation 0.6771 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-1) | 0.066 units on a scale*hours | Standard Deviation 0.2057 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Facial Pain/ Pressure: AUE (0-2) | 0.184 units on a scale*hours | Standard Deviation 0.627 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour | Nasal Congestion: AUE (0-1) | 0.250 units on a scale*hours | Standard Deviation 0.3269 |
Other Pre-specified
Subject Rating Scale for Nasal Effects: Peak Effect (Emax)
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). Emax = Maximum observed score.
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Facial Pain/ Pressure | 0.0 units on a scale | Standard Deviation 0.19 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Need to Blow Nose | 0.1 units on a scale | Standard Deviation 0.37 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Nasal Congestion | 0.1 units on a scale | Standard Deviation 0.46 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Runny Nose/ Nasal Discharge | 0.0 units on a scale | Standard Deviation 0.33 |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Burning | 0.0 units on a scale | Standard Deviation 0 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Runny Nose/ Nasal Discharge | 0.1 units on a scale | Standard Deviation 0.57 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Facial Pain/ Pressure | 0.0 units on a scale | Standard Deviation 0.26 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Need to Blow Nose | 0.1 units on a scale | Standard Deviation 0.61 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Burning | 0.1 units on a scale | Standard Deviation 0.25 |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Nasal Congestion | 0.2 units on a scale | Standard Deviation 0.77 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Runny Nose/ Nasal Discharge | 0.3 units on a scale | Standard Deviation 0.98 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Need to Blow Nose | 0.1 units on a scale | Standard Deviation 0.51 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Burning | 0.0 units on a scale | Standard Deviation 0.32 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Facial Pain/ Pressure | 0.1 units on a scale | Standard Deviation 0.37 |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Nasal Congestion | 0.4 units on a scale | Standard Deviation 1.1 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Facial Pain/ Pressure | 0.3 units on a scale | Standard Deviation 0.67 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Need to Blow Nose | 0.4 units on a scale | Standard Deviation 0.8 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Burning | 0.5 units on a scale | Standard Deviation 0.88 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Runny Nose/ Nasal Discharge | 0.4 units on a scale | Standard Deviation 0.84 |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Peak Effect (Emax) | Nasal Congestion | 0.4 units on a scale | Standard Deviation 0.84 |
Other Pre-specified
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). TEmax = Time to maximum observed score.
Time frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Facial Pain/ Pressure | 0.517 hours |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Need to Blow Nose | 0.517 hours |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Burning | 0.517 hours |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Runny Nose/ Nasal Discharge | 0.517 hours |
| Placebo Sugar Spheres | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Nasal Congestion | 0.517 hours |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Runny Nose/ Nasal Discharge | 0.517 hours |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Burning | 0.517 hours |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Facial Pain/ Pressure | 0.517 hours |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Need to Blow Nose | 0.517 hours |
| ALO-02 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Nasal Congestion | 0.517 hours |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Facial Pain/ Pressure | 0.517 hours |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Nasal Congestion | 0.517 hours |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Need to Blow Nose | 0.517 hours |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Runny Nose/ Nasal Discharge | 0.517 hours |
| Placebo Lactose Tablet | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Burning | 0.517 hours |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Nasal Congestion | 0.525 hours |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Need to Blow Nose | 0.517 hours |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Runny Nose/ Nasal Discharge | 0.517 hours |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Facial Pain/ Pressure | 0.517 hours |
| Oxycodone 30 mg | Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) | Burning | 0.517 hours |
Other Pre-specified
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Sugar Spheres | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol | Naltrexone | 0.317 hours |
| Placebo Sugar Spheres | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol | 6-Beta-naltrexol | 2.05 hours |
Other Pre-specified
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
Time frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
Population: Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Sugar Spheres | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 1.59 hours |
| Placebo Sugar Spheres | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 29, 32) | 2.05 hours |
| Placebo Sugar Spheres | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 30, 32) | 2.08 hours |
| ALO-02 30 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxycodone (n = 30, 32) | 0.475 hours |
| ALO-02 30 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Oxymorphone (n = 29, 32) | 2.55 hours |
| ALO-02 30 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Noroxycodone (n = 30, 32) | 4.05 hours |