Trial Outcomes & Findings for A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted (NCT NCT01775189)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

45 participants

Primary outcome timeframe

Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Results posted on

2017-07-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Naloxone Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 30 mg then placebo or placebo then oxycodone HCl 30 mg group in the drug discrimination phase of the study.	Oxycodone HCl 30 mg Then Placebo Single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive oxycodone HCl 30 mg and naltrexone HCl 3.6 mg extended-release (ALO-02) 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (placebo sugar spheres, PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (placebo lactose tablet, PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.	Placebo Then Oxycodone HCl 30 mg Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive ALO-02 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.	PBO Lac, OXY 30 mg, ALO-02 30 mg, PBO SS Single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in first intervention period; followed by single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in second intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	ALO-02 30 mg, PBO Lac, PBO SS, OXY 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in second intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 30 mg, PBO SS, PBO Lac, ALO-02 30 mg Single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in first intervention period; followed by single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in third intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	PBO SS, ALO-02 30 mg, OXY 30 mg, PBO Lac Single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in third intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
Naloxone Challenge Phase STARTED	45	0	0	0	0	0	0
Naloxone Challenge Phase COMPLETED	45	0	0	0	0	0	0
Naloxone Challenge Phase NOT COMPLETED	0	0	0	0	0	0	0
Drug Discrimination Phase: Day 1 STARTED	0	22	23	0	0	0	0
Drug Discrimination Phase: Day 1 COMPLETED	0	19	23	0	0	0	0
Drug Discrimination Phase: Day 1 NOT COMPLETED	0	3	0	0	0	0	0
Drug Discrimination Phase: Day 2 STARTED	0	19	23	0	0	0	0
Drug Discrimination Phase: Day 2 COMPLETED	0	16	16	0	0	0	0
Drug Discrimination Phase: Day 2 NOT COMPLETED	0	3	7	0	0	0	0
Treatment Phase: First Intervention STARTED	0	0	0	8	8	8	8
Treatment Phase: First Intervention COMPLETED	0	0	0	8	8	8	8
Treatment Phase: First Intervention NOT COMPLETED	0	0	0	0	0	0	0
Treatment Phase: Washout Period 1 STARTED	0	0	0	8	8	8	8
Treatment Phase: Washout Period 1 COMPLETED	0	0	0	8	8	7	8
Treatment Phase: Washout Period 1 NOT COMPLETED	0	0	0	0	0	1	0
Treatment Phase: Second Intervention STARTED	0	0	0	8	8	7	8
Treatment Phase: Second Intervention COMPLETED	0	0	0	8	8	7	8
Treatment Phase: Second Intervention NOT COMPLETED	0	0	0	0	0	0	0
Treatment Phase: Washout Period 2 STARTED	0	0	0	8	8	7	8
Treatment Phase: Washout Period 2 COMPLETED	0	0	0	7	8	7	8
Treatment Phase: Washout Period 2 NOT COMPLETED	0	0	0	1	0	0	0
Treatment Phase: Third Intervention STARTED	0	0	0	7	8	7	8
Treatment Phase: Third Intervention COMPLETED	0	0	0	7	8	7	8
Treatment Phase: Third Intervention NOT COMPLETED	0	0	0	0	0	0	0
Treatment Phase: Washout Period 3 STARTED	0	0	0	7	8	7	8
Treatment Phase: Washout Period 3 COMPLETED	0	0	0	6	8	7	7
Treatment Phase: Washout Period 3 NOT COMPLETED	0	0	0	1	0	0	1
Treatment Phase: Fourth Intervention STARTED	0	0	0	6	8	7	7
Treatment Phase: Fourth Intervention COMPLETED	0	0	0	6	8	7	7
Treatment Phase: Fourth Intervention NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxycodone HCl 30 mg Then Placebo Single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive oxycodone HCl 30 mg and naltrexone HCl 3.6 mg extended-release (ALO-02) 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (placebo sugar spheres, PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (placebo lactose tablet, PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.	Placebo Then Oxycodone HCl 30 mg Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on Day 1 followed by single dose of oxycodone HCl 30 mg crushed tablet intranasally on Day 2. Participants were assigned to receive ALO-02 30 mg/3.6 mg crushed capsule, placebo matched to ALO-02 30 mg/3.6 mg crushed capsule (PBO SS), oxycodone 30 mg crushed tablet (OXY 30 mg), placebo matched to oxycodone 30 mg crushed tablet (PBO Lac), intranasally, in any of the 4 sequences in the treatment phase of the study.	PBO Lac, OXY 30 mg, ALO-02 30 mg, PBO SS Single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in first intervention period; followed by single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in second intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in third intervention period; then single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 30 mg, PBO SS, PBO Lac, ALO-02 30 mg Single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in first intervention period; followed by single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in third intervention period; then single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	PBO SS, ALO-02 30 mg, OXY 30 mg, PBO Lac Single dose of placebo matched to ALO-02 (PBO SS) 30 mg/3.6 mg crushed capsule intranasally in first intervention period; followed by single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in second intervention period; then single dose of oxycodone HCl 30 mg (OXY 30 mg) crushed tablet intranasally in third intervention period; then single dose of placebo matched to oxycodone (PBO Lac) 30 mg crushed tablet intranasally in fourth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
Drug Discrimination Phase: Day 1 Adverse Event	3	0	0	0	0
Drug Discrimination Phase: Day 2 Protocol Violation	1	0	0	0	0
Drug Discrimination Phase: Day 2 Did Not Meet Entrance Criteria	2	7	0	0	0
Treatment Phase: Washout Period 1 Protocol Violation	0	0	0	1	0
Treatment Phase: Washout Period 2 Protocol Violation	0	0	1	0	0
Treatment Phase: Washout Period 3 Protocol Violation	0	0	1	0	1

Baseline Characteristics

A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=45 Participants Included all participants enrolled in the study.
Age, Continuous	35.6 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Drug Liking: Peak Effect (Emax)	50.9 mm Standard Deviation 1.18	60.5 mm Standard Deviation 12.05	51.3 mm Standard Deviation 3.32	92.8 mm Standard Deviation 11.98	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour	98.518 hours*mm Standard Deviation 6.7606	105.286 hours*mm Standard Deviation 21.3736	100.241 hours*mm Standard Deviation 3.3227	159.580 hours*mm Standard Deviation 32.1643	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
High: Peak Effect (Emax)	2.2 mm Standard Deviation 10.01	26.6 mm Standard Deviation 28.44	6.0 mm Standard Deviation 21.84	85.8 mm Standard Deviation 24.34	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
High: Area Under Effect Curve (AUE) From 0-2 Hour	0.871 hours*mm Standard Deviation 3.5082	27.750 hours*mm Standard Deviation 39.7213	4.768 hours*mm Standard Deviation 20.0468	135.670 hours*mm Standard Deviation 43.0513	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Take Drug Again: Peak Effect (Emax)	48.0 mm Standard Deviation 14.91	58.3 mm Standard Deviation 31.99	46.6 mm Standard Deviation 18.75	87.8 mm Standard Deviation 26.69	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Take Drug Again: Mean Effect (Emean)	44.71 mm Standard Deviation 14.286	52.16 mm Standard Deviation 30.926	43.95 mm Standard Deviation 17.753	85.34 mm Standard Deviation 26.860	—	—	—

SECONDARY outcome

Timeframe: 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.

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").

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Take Drug Again Effect at Hours 12 and 24 Hour 12	43.4 mm Standard Deviation 17.36	51.5 mm Standard Deviation 32.74	43.2 mm Standard Deviation 18.02	87.4 mm Standard Deviation 26.68	—	—	—
Take Drug Again Effect at Hours 12 and 24 Hour 24	46.1 mm Standard Deviation 17.40	52.8 mm Standard Deviation 32.62	44.7 mm Standard Deviation 20.66	83.3 mm Standard Deviation 28.34	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Overall Drug Liking: Peak Effect (Emax)	50.5 mm Standard Deviation 0.84	59.9 mm Standard Deviation 21.70	51.5 mm Standard Deviation 6.59	85.1 mm Standard Deviation 23.84	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Overall Drug Liking: Mean Effect (Emean)	50.32 mm Standard Deviation 0.641	56.77 mm Standard Deviation 20.058	49.16 mm Standard Deviation 8.131	81.25 mm Standard Deviation 24.081	—	—	—

SECONDARY outcome

Timeframe: 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.

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").

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Overall Drug Liking Effect at Hours 12 and 24 Hour 12	50.3 mm Standard Deviation 0.53	56.0 mm Standard Deviation 20.69	50.5 mm Standard Deviation 2.28	81.8 mm Standard Deviation 25.73	—	—	—
Overall Drug Liking Effect at Hours 12 and 24 Hour 24	50.4 mm Standard Deviation 0.87	57.6 mm Standard Deviation 21.34	47.8 mm Standard Deviation 15.02	80.8 mm Standard Deviation 25.05	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Any Drug Effects: Peak Effect (Emax)	0.6 mm Standard Deviation 1.42	35.5 mm Standard Deviation 31.81	6.2 mm Standard Deviation 17.51	88.6 mm Standard Deviation 21.28	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	18.647 hours*mm Standard Deviation 21.1164	1.692 hours*mm Standard Deviation 7.6048	69.692 hours*mm Standard Deviation 21.7465	—	—	—
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	82.371 hours*mm Standard Deviation 117.8336	12.513 hours*mm Standard Deviation 54.8407	329.004 hours*mm Standard Deviation 197.0154	—	—	—
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	96.013 hours*mm Standard Deviation 138.6860	12.585 hours*mm Standard Deviation 54.8265	399.719 hours*mm Standard Deviation 311.1514	—	—	—
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	38.290 hours*mm Standard Deviation 43.2746	3.701 hours*mm Standard Deviation 16.0503	138.888 hours*mm Standard Deviation 48.0836	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 24.02	0.517 hours Interval 0.25 to 12.02	0.250 hours Interval 0.23 to 8.0	0.267 hours Interval 0.25 to 3.02	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Good Drug Effects: Peak Effect (Emax)	4.3 mm Standard Deviation 13.70	25.6 mm Standard Deviation 29.60	8.4 mm Standard Deviation 17.98	87.9 mm Standard Deviation 21.04	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	14.263 hours*mm Standard Deviation 20.5630	2.393 hours*mm Standard Deviation 9.4972	69.464 hours*mm Standard Deviation 21.0703	—	—	—
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	26.603 hours*mm Standard Deviation 39.6360	5.161 hours*mm Standard Deviation 20.4142	138.679 hours*mm Standard Deviation 45.7222	—	—	—
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	58.746 hours*mm Standard Deviation 110.6803	14.795 hours*mm Standard Deviation 62.5301	307.589 hours*mm Standard Deviation 191.3034	—	—	—
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	69.246 hours*mm Standard Deviation 136.6847	14.795 hours*mm Standard Deviation 62.5301	348.732 hours*mm Standard Deviation 274.1036	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 8.02	0.275 hours Interval 0.25 to 2.52	0.250 hours Interval 0.23 to 3.0	0.400 hours Interval 0.25 to 1.52	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Bad Drug Effects: Peak Effect (Emax)	1.4 mm Standard Deviation 5.49	13.0 mm Standard Deviation 24.52	5.6 mm Standard Deviation 15.92	18.5 mm Standard Deviation 26.24	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	3.911 hours*mm Standard Deviation 7.8416	0.246 hours*mm Standard Deviation 1.2050	4.080 hours*mm Standard Deviation 9.9234	—	—	—
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	6.920 hours*mm Standard Deviation 12.0601	0.701 hours*mm Standard Deviation 3.6120	10.107 hours*mm Standard Deviation 21.5289	—	—	—
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	15.000 hours*mm Standard Deviation 31.8735	5.719 hours*mm Standard Deviation 20.3316	43.232 hours*mm Standard Deviation 87.5335	—	—	—
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	19.214 hours*mm Standard Deviation 45.0219	6.004 hours*mm Standard Deviation 20.3044	71.375 hours*mm Standard Deviation 192.3920	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 24.02	0.267 hours Interval 0.25 to 2.52	0.250 hours Interval 0.23 to 12.0	0.642 hours Interval 0.25 to 12.02	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Feel Sick: Peak Effect (Emax)	2.1 mm Standard Deviation 9.23	8.7 mm Standard Deviation 20.50	3.9 mm Standard Deviation 13.34	4.6 mm Standard Deviation 21.95	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	1.549 hours*mm Standard Deviation 5.3704	0.232 hours*mm Standard Deviation 1.2041	0.442 hours*mm Standard Deviation 1.5106	—	—	—
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	3.424 hours*mm Standard Deviation 8.1912	0.714 hours*mm Standard Deviation 3.6100	3.049 hours*mm Standard Deviation 8.5600	—	—	—
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 4.6220	9.371 hours*mm Standard Deviation 22.4283	4.804 hours*mm Standard Deviation 19.8483	25.103 hours*mm Standard Deviation 80.5454	—	—	—
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	10.513 hours*mm Standard Deviation 24.8145	4.875 hours*mm Standard Deviation 19.8377	42.460 hours*mm Standard Deviation 144.3171	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Feel Sick: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 4.0	0.267 hours Interval 0.25 to 6.0	0.250 hours Interval 0.23 to 8.0	0.267 hours Interval 0.25 to 8.02	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Nausea: Peak Effect (Emax)	1.9 mm Standard Deviation 9.25	9.3 mm Standard Deviation 20.99	5.3 mm Standard Deviation 15.90	12.3 mm Standard Deviation 29.94	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	2.455 hours*mm Standard Deviation 5.9882	0.290 hours*mm Standard Deviation 1.2186	2.339 hours*mm Standard Deviation 6.0186	—	—	—
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	5.179 hours*mm Standard Deviation 11.0690	0.781 hours*mm Standard Deviation 3.6209	7.357 hours*mm Standard Deviation 15.8889	—	—	—
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	9.063 hours*mm Standard Deviation 17.1052	5.353 hours*mm Standard Deviation 19.5238	46.402 hours*mm Standard Deviation 114.6615	—	—	—
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	10.848 hours*mm Standard Deviation 23.1275	5.638 hours*mm Standard Deviation 19.5807	58.759 hours*mm Standard Deviation 150.9858	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Nausea: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 4.02	0.267 hours Interval 0.25 to 6.0	0.250 hours Interval 0.23 to 2.52	0.267 hours Interval 0.25 to 8.02	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Sleepy: Peak Effect (Emax)	7.6 mm Standard Deviation 21.35	35.0 mm Standard Deviation 36.04	11.1 mm Standard Deviation 28.41	62.9 mm Standard Deviation 36.25	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	8.848 hours*mm Standard Deviation 13.8043	2.920 hours*mm Standard Deviation 6.8778	20.464 hours*mm Standard Deviation 21.9449	—	—	—
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	34.571 hours*mm Standard Deviation 40.4452	8.089 hours*mm Standard Deviation 19.0222	61.750 hours*mm Standard Deviation 48.0978	—	—	—
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	125.196 hours*mm Standard Deviation 157.0183	34.438 hours*mm Standard Deviation 92.1369	304.652 hours*mm Standard Deviation 210.8188	—	—	—
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	187.839 hours*mm Standard Deviation 217.5872	64.795 hours*mm Standard Deviation 172.8842	496.652 hours*mm Standard Deviation 424.7570	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Sleepy: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 12.02	1.517 hours Interval 0.25 to 12.02	0.267 hours Interval 0.25 to 12.02	2.517 hours Interval 0.25 to 12.02	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Dizzy: Peak Effect (Emax)	4.4 mm Standard Deviation 13.34	7.4 mm Standard Deviation 15.74	4.1 mm Standard Deviation 15.02	23.5 mm Standard Deviation 36.62	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	5.134 hours*mm Standard Deviation 14.4253	1.259 hours*mm Standard Deviation 4.6194	17.737 hours*mm Standard Deviation 28.2806	—	—	—
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	8.482 hours*mm Standard Deviation 20.2822	4.938 hours*mm Standard Deviation 22.2685	48.826 hours*mm Standard Deviation 93.0141	—	—	—
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	11.768 hours*mm Standard Deviation 29.2486	5.152 hours*mm Standard Deviation 22.2481	57.469 hours*mm Standard Deviation 119.5335	—	—	—
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 0.1890	1.161 hours*mm Standard Deviation 2.7284	0.795 hours*mm Standard Deviation 3.1320	9.192 hours*mm Standard Deviation 14.5426	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Dizzy: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 8.02	0.267 hours Interval 0.25 to 12.02	0.250 hours Interval 0.23 to 24.02	0.267 hours Interval 0.25 to 6.0	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=29 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Percentage of Dose (Drug Powder) Insufflated	100.00 percentage of dose Standard Deviation 0.000	99.85 percentage of dose Standard Deviation 0.840	100.00 percentage of dose Standard Deviation 0.000	99.37 percentage of dose Standard Deviation 3.553	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=26 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=26 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Pupillometry: Peak Effect (Emax)	-0.9 mm Standard Deviation 0.60	-1.7 mm Standard Deviation 0.64	-0.7 mm Standard Deviation 0.50	-2.9 mm Standard Deviation 0.66	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=26 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=26 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	9.114 hours*mm Standard Deviation 1.6974	10.162 hours*mm Standard Deviation 1.5217	5.868 hours*mm Standard Deviation 0.8325	—	—	—
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	34.874 hours*mm Standard Deviation 6.6910	41.658 hours*mm Standard Deviation 6.0399	23.904 hours*mm Standard Deviation 3.3208	—	—	—
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	4.746 hours*mm Standard Deviation 0.8291	5.132 hours*mm Standard Deviation 0.7712	3.229 hours*mm Standard Deviation 0.4547	—	—	—
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	110.574 hours*mm Standard Deviation 19.3751	128.937 hours*mm Standard Deviation 16.8685	94.012 hours*mm Standard Deviation 12.6818	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=26 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=26 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Pupillometry: Time to Maximum (Peak) Effect (TEmax)	3.017 hours Interval 0.53 to 24.03	3.017 hours Interval 0.53 to 12.02	2.025 hours Interval 0.53 to 24.03	0.800 hours Interval 0.52 to 3.03	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	53.455 hours*mm Standard Deviation 10.0825	49.884 hours*mm Standard Deviation 2.7778	81.250 hours*mm Standard Deviation 13.1291	—	—	—
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 17.5470	414.045 hours*mm Standard Deviation 61.6430	401.036 hours*mm Standard Deviation 3.4801	540.554 hours*mm Standard Deviation 122.5684	—	—	—
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 18.4210	1223.902 hours*mm Standard Deviation 72.4917	1202.750 hours*mm Standard Deviation 6.0623	1397.911 hours*mm Standard Deviation 231.2330	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Drug Liking: Time to Maximum (Peak) Effect (TEmax)	0.383 hours Interval 0.25 to 3.02	0.758 hours Interval 0.25 to 8.0	0.500 hours Interval 0.23 to 6.02	0.383 hours Interval 0.25 to 12.02	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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	14.250 hours*mm Standard Deviation 20.4883	2.313 hours*mm Standard Deviation 9.3978	68.223 hours*mm Standard Deviation 19.7926	—	—	—
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 3.8560	60.143 hours*mm Standard Deviation 113.5249	12.955 hours*mm Standard Deviation 51.4525	290.670 hours*mm Standard Deviation 174.8869	—	—	—
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	75.429 hours*mm Standard Deviation 136.4319	16.598 hours*mm Standard Deviation 70.5151	330.813 hours*mm Standard Deviation 257.7739	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=28 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=28 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=28 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=28 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
High: Time to Maximum (Peak) Effect (TEmax)	0.258 hours Interval 0.25 to 0.52	0.275 hours Interval 0.25 to 24.0	0.250 hours Interval 0.23 to 3.0	0.517 hours Interval 0.25 to 2.03	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=29 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Subject Rating Scale for Nasal Effects: Peak Effect (Emax) Nasal Congestion	0.1 units on a scale Standard Deviation 0.46	0.2 units on a scale Standard Deviation 0.77	0.4 units on a scale Standard Deviation 1.10	0.4 units on a scale Standard Deviation 0.84	—	—	—
Subject Rating Scale for Nasal Effects: Peak Effect (Emax) Burning	0.0 units on a scale Standard Deviation 0.00	0.1 units on a scale Standard Deviation 0.25	0.0 units on a scale Standard Deviation 0.32	0.5 units on a scale Standard Deviation 0.88	—	—	—
Subject Rating Scale for Nasal Effects: Peak Effect (Emax) Need to Blow Nose	0.1 units on a scale Standard Deviation 0.37	0.1 units on a scale Standard Deviation 0.61	0.1 units on a scale Standard Deviation 0.51	0.4 units on a scale Standard Deviation 0.80	—	—	—
Subject Rating Scale for Nasal Effects: Peak Effect (Emax) Runny Nose/ Nasal Discharge	0.0 units on a scale Standard Deviation 0.33	0.1 units on a scale Standard Deviation 0.57	0.3 units on a scale Standard Deviation 0.98	0.4 units on a scale Standard Deviation 0.84	—	—	—
Subject Rating Scale for Nasal Effects: Peak Effect (Emax) Facial Pain/ Pressure	0.0 units on a scale Standard Deviation 0.19	0.0 units on a scale Standard Deviation 0.26	0.1 units on a scale Standard Deviation 0.37	0.3 units on a scale Standard Deviation 0.67	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=29 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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 0.0000	0.025 units on a scale*hours Standard Deviation 0.0951	0.033 units on a scale*hours Standard Deviation 0.1035	0.184 units on a scale*hours Standard Deviation 0.3062	—	—	—
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	0.117 units on a scale*hours Standard Deviation 0.3182	0.088 units on a scale*hours Standard Deviation 0.2503	0.293 units on a scale*hours Standard Deviation 0.4586	—	—	—
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	0.108 units on a scale*hours Standard Deviation 0.4437	0.146 units on a scale*hours Standard Deviation 0.4678	0.301 units on a scale*hours Standard Deviation 0.6771	—	—	—
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	0.175 units on a scale*hours Standard Deviation 0.3664	0.200 units on a scale*hours Standard Deviation 0.3934	0.250 units on a scale*hours Standard Deviation 0.3269	—	—	—
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 0.0000	0.025 units on a scale*hours Standard Deviation 0.0951	0.033 units on a scale*hours Standard Deviation 0.1035	0.270 units on a scale*hours Standard Deviation 0.6214	—	—	—
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	0.183 units on a scale*hours Standard Deviation 0.5520	0.088 units on a scale*hours Standard Deviation 0.2503	0.504 units on a scale*hours Standard Deviation 0.8616	—	—	—
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	0.083 units on a scale*hours Standard Deviation 0.3432	0.038 units on a scale*hours Standard Deviation 0.1046	0.184 units on a scale*hours Standard Deviation 0.3521	—	—	—
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	0.033 units on a scale*hours Standard Deviation 0.1428	0.042 units on a scale*hours Standard Deviation 0.1367	0.066 units on a scale*hours Standard Deviation 0.2057	—	—	—
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	0.050 units on a scale*hours Standard Deviation 0.2312	0.050 units on a scale*hours Standard Deviation 0.1416	0.184 units on a scale*hours Standard Deviation 0.6270	—	—	—
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	0.250 units on a scale*hours Standard Deviation 0.5835	0.242 units on a scale*hours Standard Deviation 0.4956	0.484 units on a scale*hours Standard Deviation 0.7853	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=29 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) Need to Blow Nose	0.517 hours Interval 0.5 to 0.53	0.517 hours Interval 0.5 to 0.6	0.517 hours Interval 0.48 to 0.55	0.517 hours Interval 0.5 to 1.52	—	—	—
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) Facial Pain/ Pressure	0.517 hours Interval 0.5 to 0.53	0.517 hours Interval 0.5 to 0.6	0.517 hours Interval 0.48 to 2.0	0.517 hours Interval 0.5 to 1.52	—	—	—
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) Burning	0.517 hours Interval 0.5 to 0.53	0.517 hours Interval 0.5 to 0.6	0.517 hours Interval 0.48 to 0.55	0.517 hours Interval 0.5 to 1.52	—	—	—
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) Runny Nose/ Nasal Discharge	0.517 hours Interval 0.5 to 0.53	0.517 hours Interval 0.5 to 0.75	0.517 hours Interval 0.48 to 1.52	0.517 hours Interval 0.5 to 1.52	—	—	—
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) Nasal Congestion	0.517 hours Interval 0.5 to 0.53	0.517 hours Interval 0.5 to 0.75	0.517 hours Interval 0.48 to 0.78	0.525 hours Interval 0.5 to 1.52	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone	57.93 nanogram per milliliter (ng/mL) Standard Deviation 13.706	82.63 nanogram per milliliter (ng/mL) Standard Deviation 19.877	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone	0.4613 nanogram per milliliter (ng/mL) Standard Deviation 0.25684	0.3441 nanogram per milliliter (ng/mL) Standard Deviation 0.16644	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone	29.02 nanogram per milliliter (ng/mL) Standard Deviation 10.858	18.88 nanogram per milliliter (ng/mL) Standard Deviation 6.8506	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol Naltrexone	4.574 nanogram per milliliter (ng/mL) Standard Deviation 1.4093	—	—	—	—	—	—
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 outcome

Timeframe: 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.

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone (n = 30, 32)	1.59 hours Interval 0.283 to 4.07	0.475 hours Interval 0.283 to 1.07	—	—	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone (n = 29, 32)	2.05 hours Interval 1.05 to 4.07	2.55 hours Interval 0.55 to 6.03	—	—	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone (n = 30, 32)	2.08 hours Interval 1.05 to 6.08	4.05 hours Interval 2.05 to 6.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol Naltrexone	0.317 hours Interval 0.283 to 1.57	—	—	—	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol 6-Beta-naltrexol	2.05 hours Interval 0.767 to 4.07	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone (n = 30, 32)	4.171 hours Standard Deviation 0.65437	4.134 hours Standard Deviation 0.87884	—	—	—	—	—
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone (n = 1, 1)	NA hours Standard Deviation NA Data was not reported when fewer than 3 participant were evaluable.	NA hours Standard Deviation NA Data was not reported when fewer than 3 participant were evaluable.	—	—	—	—	—
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone (n = 28, 27)	7.116 hours Standard Deviation 1.2582	7.101 hours Standard Deviation 0.89387	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol 6-beta-naltrexol (n = 11)	9.230 hours Standard Deviation 0.62809	—	—	—	—	—	—
Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol Naltrexone (n = 30)	3.577 hours Standard Deviation 0.71124	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.07603	0.1589 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.10643	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 10.010	59.56 nanogramhour/milliliter (nghr/mL) Standard Deviation 14.977	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 21.951	116.3 nanogramhour/milliliter (nghr/mL) Standard Deviation 27.449	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 64.753	328.2 nanogramhour/milliliter (nghr/mL) Standard Deviation 73.834	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.26464	0.4211 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.25186	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 1.1448	1.856 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.99704	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 4.0397	6.410 nanogramhour/milliliter (nghr/mL) Standard Deviation 2.8655	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 15.014	18.91 nanogramhour/milliliter (nghr/mL) Standard Deviation 7.1716	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 46.804	119.9 nanogramhour/milliliter (nghr/mL) Standard Deviation 40.380	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone	2.498 nanogramhour/milliliter (nghr/mL) Standard Deviation 1.6933	2.469 nanogramhour/milliliter (nghr/mL) Standard Deviation 1.8058	—	—	—	—	—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone	353.0 nanogramhour/milliliter (nghr/mL) Standard Deviation 103.13	435.3 nanogramhour/milliliter (nghr/mL) Standard Deviation 112.11	—	—	—	—	—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone	280.6 nanogramhour/milliliter (nghr/mL) Standard Deviation 95.277	248.5 nanogramhour/milliliter (nghr/mL) Standard Deviation 84.723	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=32 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone Oxycodone (n = 30, 32)	361.2 nanogramhour/milliliter (nghr/mL) Standard Deviation 109.33	447.3 nanogramhour/milliliter (nghr/mL) Standard Deviation 123.92	—	—	—	—	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone (n = 1, 1)	NA nanogramhour/milliliter (nghr/mL) Standard Deviation NA Data was not reported when fewer than 3 participant were evaluable.	NA nanogramhour/milliliter (nghr/mL) Standard Deviation NA Data was not reported when fewer than 3 participant were evaluable.	—	—	—	—	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone (n = 28, 27)	309.9 nanogramhour/milliliter (nghr/mL) Standard Deviation 111.42	288.8 nanogramhour/milliliter (nghr/mL) Standard Deviation 104.33	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.87457	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 1.4721	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 3.0400	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 0.56296	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 1.7302	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 4.8024	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol Naltrexone	11.07 nanogramhour/milliliter (nghr/mL) Standard Deviation 3.2130	—	—	—	—	—	—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol 6-beta-naltrexol	37.28 nanogramhour/milliliter (nghr/mL) Standard Deviation 9.3207	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=30 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol Naltrexone (n = 11)	10.71 nanogramhour/milliliter (nghr/mL) Standard Deviation 11.13	—	—	—	—	—	—
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 nanogramhour/milliliter (nghr/mL) Standard Deviation 10.544	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=45 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=45 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=42 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=29 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	1 participants	43 participants	8 participants	6 participants	18 participants	10 participants	32 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=45 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=45 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=42 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=29 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Number of Participants With Clinically Significant Change in Vital Sign Examinations	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=29 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)	0 participants	0 participants	0 participants	0 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Sugar Spheres n=45 Participants Single dose of placebo matched to ALO-02 crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=42 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=29 Participants Single dose of placebo matched to oxycodone crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=30 Participants Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 Participants Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=32 Participants Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

Adverse Events

Naloxone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Oxycodone HCl 30 mg

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo Oxycodone HCl

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Sugar Spheres

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ALO-02 30 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo Lactose Tablet

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Oxycodone 30 mg

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naloxone n=45 participants at risk Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase.	Oxycodone HCl 30 mg n=45 participants at risk Single dose of oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.	Placebo Oxycodone HCl n=45 participants at risk；n=42 participants at risk Single dose of placebo matched to oxycodone HCl 30 mg crushed tablet intranasally on either of 2 days in drug discrimination phase.	Placebo Sugar Spheres n=29 participants at risk Single dose of placebo matched to ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	ALO-02 30 mg n=30 participants at risk Single dose of ALO-02 30 mg/3.6 mg crushed capsule intranasally in any of the first to fourth intervention periods.	Placebo Lactose Tablet n=30 participants at risk Single dose of placebo matched to oxycodone 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.	Oxycodone 30 mg n=32 participants at risk Single dose of oxycodone HCl 30 mg crushed tablet intranasally in any of the first to fourth intervention periods.
Gastrointestinal disorders Dry mouth	0.00% 0/45	4.4% 2/45	0.00% 0/45	0.00% 0/29	0.00% 0/30	0.00% 0/30	6.2% 2/32
Gastrointestinal disorders Nausea	0.00% 0/45	13.3% 6/45	0.00% 0/45	0.00% 0/29	6.7% 2/30	0.00% 0/30	15.6% 5/32
General disorders Fatigue	0.00% 0/45	17.8% 8/45	0.00% 0/45	3.4% 1/29	13.3% 4/30	6.7% 2/30	9.4% 3/32
General disorders Feeling hot	0.00% 0/45	13.3% 6/45	0.00% 0/45	0.00% 0/29	6.7% 2/30	0.00% 0/30	9.4% 3/32
General disorders Feeling of relaxation	0.00% 0/45	2.2% 1/45	0.00% 0/45	0.00% 0/29	3.3% 1/30	0.00% 0/30	6.2% 2/32
Nervous system disorders Dizziness	0.00% 0/45	15.6% 7/45	2.2% 1/45	0.00% 0/29	3.3% 1/30	0.00% 0/30	6.2% 2/32
Nervous system disorders Dysgeusia	0.00% 0/45	0.00% 0/45	0.00% 0/45	3.4% 1/29	20.0% 6/30	6.7% 2/30	3.1% 1/32
Nervous system disorders Headache	2.2% 1/45	2.2% 1/45	2.2% 1/45	0.00% 0/29	10.0% 3/30	10.0% 3/30	9.4% 3/32
Nervous system disorders Somnolence	0.00% 0/45	44.4% 20/45	2.2% 1/45	3.4% 1/29	13.3% 4/30	3.3% 1/30	37.5% 12/32
Psychiatric disorders Euphoric mood	0.00% 0/45	91.1% 41/45	4.4% 2/45	3.4% 1/29	33.3% 10/30	0.00% 0/30	84.4% 27/32
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/45	0.00% 0/45	0.00% 0/45	0.00% 0/29	0.00% 0/30	0.00% 0/30	6.2% 2/32
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/45	0.00% 0/45	0.00% 0/45	3.4% 1/29	0.00% 0/30	0.00% 0/30	15.6% 5/32
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/45	6.7% 3/45	0.00% 0/45	0.00% 0/29	6.7% 2/30	0.00% 0/30	6.2% 2/32
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/45	53.3% 24/45	2.2% 1/45	0.00% 0/29	0.00% 0/30	0.00% 0/30	75.0% 24/32
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/45	6.7% 3/45	0.00% 0/45	0.00% 0/29	0.00% 0/30	0.00% 0/30	3.1% 1/32

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER