Trial Outcomes & Findings for A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers (NCT NCT01746901)

NCT ID: NCT01746901

Last Updated: 2018-10-19

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: 81 participants
• Primary outcome timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase
• Results posted on: 2018-10-19

Participant Flow

Recreational opioid users who 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

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 40 mg then placebo or placebo then oxycodone HCl 40 mg group in the drug discrimination phase of the study.	Oxycodone HCl 40 mg Then PBO Single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 1 followed by single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.	PBO Then Oxycodone HCl 40 mg Single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 1 followed by single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.	ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in second intervention period; then single dose of matching placebo (PBO) orally on Day 1 in third intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on orally on Day 1 in second intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in third intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of matching placebo (PBO) orally on Day 1 in second intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in third intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fifth intervention period; then by single dose of matching placebo (PBO) orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg Single dose of matching placebo (PBO) orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in second intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 40 mg/4.8 mg crushed capsule (ALO-02 40 mg-I) solution orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
Naloxone Challenge Phase STARTED	75	0	0	0	0	0	0	0	0
Naloxone Challenge Phase COMPLETED	72	0	0	0	0	0	0	0	0
Naloxone Challenge Phase NOT COMPLETED	3	0	0	0	0	0	0	0	0
Drug Discrimination Phase: Day 1 STARTED	0	36	36	0	0	0	0	0	0
Drug Discrimination Phase: Day 1 COMPLETED	0	33	36	0	0	0	0	0	0
Drug Discrimination Phase: Day 1 NOT COMPLETED	0	3	0	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 STARTED	0	33	36	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 COMPLETED	0	19	22	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 NOT COMPLETED	0	14	14	0	0	0	0	0	0
Treatment Phase: First Intervention STARTED	0	0	0	6	6	7	8	7	7
Treatment Phase: First Intervention COMPLETED	0	0	0	6	6	7	7	7	7
Treatment Phase: First Intervention NOT COMPLETED	0	0	0	0	0	0	1	0	0
Treatment Phase: Washout Period 1 STARTED	0	0	0	6	6	7	7	7	7
Treatment Phase: Washout Period 1 COMPLETED	0	0	0	6	6	7	7	7	7
Treatment Phase: Washout Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Second Intervention STARTED	0	0	0	6	6	7	7	7	7
Treatment Phase: Second Intervention COMPLETED	0	0	0	6	6	7	7	6	7
Treatment Phase: Second Intervention NOT COMPLETED	0	0	0	0	0	0	0	1	0
Treatment Phase: Washout Period 2 STARTED	0	0	0	6	6	7	7	6	7
Treatment Phase: Washout Period 2 COMPLETED	0	0	0	6	6	7	7	6	7
Treatment Phase: Washout Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Third Intervention STARTED	0	0	0	6	6	7	7	6	7
Treatment Phase: Third Intervention COMPLETED	0	0	0	6	6	6	6	6	7
Treatment Phase: Third Intervention NOT COMPLETED	0	0	0	0	0	1	1	0	0
Treatment Phase: Washout Period 3 STARTED	0	0	0	6	6	6	6	6	7
Treatment Phase: Washout Period 3 COMPLETED	0	0	0	6	6	6	6	6	7
Treatment Phase: Washout Period 3 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Fourth Intervention STARTED	0	0	0	6	6	6	6	6	7
Treatment Phase: Fourth Intervention COMPLETED	0	0	0	5	6	5	5	6	5
Treatment Phase: Fourth Intervention NOT COMPLETED	0	0	0	1	0	1	1	0	2
Treatment Phase: Washout Period 4 STARTED	0	0	0	5	6	5	5	6	5
Treatment Phase: Washout Period 4 COMPLETED	0	0	0	5	6	5	5	6	5
Treatment Phase: Washout Period 4 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Fifth Intervention STARTED	0	0	0	5	6	5	5	6	5
Treatment Phase: Fifth Intervention COMPLETED	0	0	0	5	6	5	5	6	5
Treatment Phase: Fifth Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Washout Period 5 STARTED	0	0	0	5	6	5	5	6	5
Treatment Phase: Washout Period 5 COMPLETED	0	0	0	5	6	5	5	6	5
Treatment Phase: Washout Period 5 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Treatment Phase: Sixth Intervention STARTED	0	0	0	5	6	5	5	6	5
Treatment Phase: Sixth Intervention COMPLETED	0	0	0	5	6	5	5	6	5
Treatment Phase: Sixth Intervention NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

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 40 mg then placebo or placebo then oxycodone HCl 40 mg group in the drug discrimination phase of the study.	Oxycodone HCl 40 mg Then PBO Single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 1 followed by single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.	PBO Then Oxycodone HCl 40 mg Single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 1 followed by single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study.	ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in second intervention period; then single dose of matching placebo (PBO) orally on Day 1 in third intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on orally on Day 1 in second intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in third intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of matching placebo (PBO) orally on Day 1 in second intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in third intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fifth intervention period; then by single dose of matching placebo (PBO) orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.	PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg Single dose of matching placebo (PBO) orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in second intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 40 mg/4.8 mg crushed capsule (ALO-02 40 mg-I) solution orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
Naloxone Challenge Phase Adverse Event	2	0	0	0	0	0	0	0	0
Naloxone Challenge Phase Did not meet entrance criteria	1	0	0	0	0	0	0	0	0
Drug Discrimination Phase: Day 1 Adverse Event	0	3	0	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 Adverse Event	0	2	1	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 Did not met entrance criteria	0	9	10	0	0	0	0	0	0
Drug Discrimination Phase: Day 2 Protocol Violation	0	3	3	0	0	0	0	0	0
Treatment Phase: First Intervention Protocol Violation	0	0	0	0	0	0	1	0	0
Treatment Phase: Second Intervention Withdrawal by Subject	0	0	0	0	0	0	0	1	0
Treatment Phase: Third Intervention Protocol Violation	0	0	0	0	0	1	1	0	0
Treatment Phase: Fourth Intervention Lost to Follow-up	0	0	0	1	0	0	0	0	0
Treatment Phase: Fourth Intervention Adverse Event	0	0	0	0	0	1	0	0	1
Treatment Phase: Fourth Intervention Protocol Violation	0	0	0	0	0	0	1	0	1

Baseline Characteristics

A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

Baseline characteristics by cohort

Measure	Entire Study Population n=75 Participants Included all participants enrolled in the study.
Age, Continuous	38.6 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

Population: Completer analysis set included all randomized participants who completed all 6 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Drug Liking: Peak Effect (Emax)	59.3 mm Standard Deviation 15.09	74.4 mm Standard Deviation 18.10	89.7 mm Standard Deviation 13.59	51.6 mm Standard Deviation 3.74	70.1 mm Standard Deviation 19.23	85.5 mm Standard Deviation 16.11	—	—	—

PRIMARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour	100.188 hours*mm Standard Deviation 10.6437	127.320 hours*mm Standard Deviation 31.2906	149.484 hours*mm Standard Deviation 24.1907	100.004 hours*mm Standard Deviation 5.1468	118.480 hours*mm Standard Deviation 28.7707	141.305 hours*mm Standard Deviation 32.9203	—	—	—

PRIMARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
High: Peak Effect (Emax)	21.7 mm Standard Deviation 35.36	53.4 mm Standard Deviation 34.68	84.7 mm Standard Deviation 23.67	10.9 mm Standard Deviation 20.60	47.3 mm Standard Deviation 36.88	77.9 mm Standard Deviation 25.46	—	—	—

PRIMARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
High: Area Under Effect Curve (AUE) From 0-2 Hour	9.902 hours*mm Standard Deviation 21.1911	71.254 hours*mm Standard Deviation 55.9812	117.578 hours*mm Standard Deviation 42.2152	2.496 hours*mm Standard Deviation 8.3003	55.250 hours*mm Standard Deviation 54.1280	112.082 hours*mm Standard Deviation 43.7000	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Take Drug Again: Peak Effect (Emax)	48.1 mm Standard Deviation 28.14	72.0 mm Standard Deviation 28.31	81.3 mm Standard Deviation 25.23	45.7 mm Standard Deviation 19.05	57.9 mm Standard Deviation 33.58	83.4 mm Standard Deviation 20.26	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Take Drug Again: Mean Effect (Emean)	42.63 mm Standard Deviation 26.293	68.78 mm Standard Deviation 29.883	78.02 mm Standard Deviation 24.868	42.90 mm Standard Deviation 20.002	54.71 mm Standard Deviation 32.635	77.80 mm Standard Deviation 22.880	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Take Drug Again: Minimum Effect (Emin)	37.8 mm Standard Deviation 28.72	66.3 mm Standard Deviation 31.57	75.2 mm Standard Deviation 24.85	41.1 mm Standard Deviation 21.60	50.9 mm Standard Deviation 32.46	73.2 mm Standard Deviation 26.92	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Take Drug Again Effect at Hours 12, 24 and 36 Hour 12	45.8 mm Standard Deviation 27.53	68.7 mm Standard Deviation 30.31	78.9 mm Standard Deviation 25.21	44.0 mm Standard Deviation 20.63	54.7 mm Standard Deviation 33.56	79.7 mm Standard Deviation 22.37	—	—	—
Take Drug Again Effect at Hours 12, 24 and 36 Hour 24	41.0 mm Standard Deviation 28.73	69.6 mm Standard Deviation 28.34	78.3 mm Standard Deviation 25.17	41.8 mm Standard Deviation 21.79	55.5 mm Standard Deviation 32.73	76.9 mm Standard Deviation 26.77	—	—	—
Take Drug Again Effect at Hours 12, 24 and 36 Hour 36	41.1 mm Standard Deviation 28.95	68.1 mm Standard Deviation 31.99	76.8 mm Standard Deviation 25.17	42.9 mm Standard Deviation 20.40	53.9 mm Standard Deviation 32.84	76.8 mm Standard Deviation 25.12	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Drug Liking: Peak Effect (Emax)	52.9 mm Standard Deviation 21.33	74.0 mm Standard Deviation 22.44	81.6 mm Standard Deviation 23.15	50.8 mm Standard Deviation 12.80	64.3 mm Standard Deviation 24.00	80.8 mm Standard Deviation 19.51	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Drug Liking: Mean Effect (Emean)	47.72 mm Standard Deviation 20.715	69.94 mm Standard Deviation 23.370	77.90 mm Standard Deviation 23.077	50.19 mm Standard Deviation 11.962	61.26 mm Standard Deviation 24.489	75.70 mm Standard Deviation 21.304	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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"). Emin= Average observed score.

Outcome measures

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Drug Liking: Minimum Effect (Emin)	43.6 mm Standard Deviation 23.55	65.6 mm Standard Deviation 25.87	74.3 mm Standard Deviation 23.53	49.6 mm Standard Deviation 11.40	58.5 mm Standard Deviation 24.82	71.1 mm Standard Deviation 25.28	—	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Drug Liking Effect at Hours 12, 24 and 36 Hour 12	51.8 mm Standard Deviation 21.57	69.8 mm Standard Deviation 23.19	78.1 mm Standard Deviation 23.99	50.6 mm Standard Deviation 12.78	61.2 mm Standard Deviation 26.16	78.5 mm Standard Deviation 20.86	—	—	—
Overall Drug Liking Effect at Hours 12, 24 and 36 Hour 24	44.8 mm Standard Deviation 23.62	70.1 mm Standard Deviation 24.53	78.1 mm Standard Deviation 22.95	50.3 mm Standard Deviation 11.84	62.7 mm Standard Deviation 23.25	75.5 mm Standard Deviation 24.26	—	—	—
Overall Drug Liking Effect at Hours 12, 24 and 36 Hour 36	46.6 mm Standard Deviation 23.35	69.9 mm Standard Deviation 25.43	77.6 mm Standard Deviation 23.79	49.7 mm Standard Deviation 11.41	59.9 mm Standard Deviation 25.20	73.2 mm Standard Deviation 25.03	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Any Drug Effects: Peak Effect (Emax)	27.7 mm Standard Deviation 35.77	56.0 mm Standard Deviation 35.90	88.7 mm Standard Deviation 20.52	8.8 mm Standard Deviation 19.43	47.2 mm Standard Deviation 38.45	82.4 mm Standard Deviation 25.27	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	4.539 hours*mm Standard Deviation 11.9639	26.566 hours*mm Standard Deviation 24.8693	48.328 hours*mm Standard Deviation 19.8494	1.105 hours*mm Standard Deviation 5.6058	20.129 hours*mm Standard Deviation 23.9971	40.199 hours*mm Standard Deviation 20.3489	—	—	—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	10.734 hours*mm Standard Deviation 23.0043	69.059 hours*mm Standard Deviation 55.0442	124.617 hours*mm Standard Deviation 41.2197	3.090 hours*mm Standard Deviation 10.1113	57.504 hours*mm Standard Deviation 57.6543	112.910 hours*mm Standard Deviation 41.6661	—	—	—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	53.242 hours*mm Standard Deviation 99.4186	167.137 hours*mm Standard Deviation 152.8249	354.391 hours*mm Standard Deviation 184.4799	5.949 hours*mm Standard Deviation 16.4695	140.152 hours*mm Standard Deviation 147.5551	283.770 hours*mm Standard Deviation 173.4241	—	—	—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	107.180 hours*mm Standard Deviation 190.7655	176.199 hours*mm Standard Deviation 165.0887	392.828 hours*mm Standard Deviation 229.3565	5.949 hours*mm Standard Deviation 16.4695	156.652 hours*mm Standard Deviation 175.1035	317.270 hours*mm Standard Deviation 218.4262	—	—	—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	218.805 hours*mm Standard Deviation 379.7129	184.137 hours*mm Standard Deviation 172.7494	402.516 hours*mm Standard Deviation 244.3471	13.762 hours*mm Standard Deviation 46.7425	157.059 hours*mm Standard Deviation 175.7028	345.301 hours*mm Standard Deviation 260.4659	—	—	—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	235.117 hours*mm Standard Deviation 424.9088	186.387 hours*mm Standard Deviation 173.5877	402.703 hours*mm Standard Deviation 244.2750	23.324 hours*mm Standard Deviation 98.1331	157.059 hours*mm Standard Deviation 175.7028	345.488 hours*mm Standard Deviation 260.3746	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.758 hours Interval 0.25 to 14.02	1.258 hours Interval 0.25 to 8.03	1.017 hours Interval 0.48 to 3.07	0.258 hours Interval 0.25 to 24.02	1.017 hours Interval 0.25 to 5.03	1.017 hours Interval 0.27 to 4.0	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Good Drug Effects: Peak Effect (Emax)	24.2 mm Standard Deviation 34.68	54.7 mm Standard Deviation 36.16	84.3 mm Standard Deviation 22.53	11.6 mm Standard Deviation 24.91	48.1 mm Standard Deviation 38.53	81.8 mm Standard Deviation 24.54	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	10.543 hours*mm Standard Deviation 22.1051	71.305 hours*mm Standard Deviation 58.7340	114.953 hours*mm Standard Deviation 41.8081	3.055 hours*mm Standard Deviation 10.0140	56.352 hours*mm Standard Deviation 55.7819	110.430 hours*mm Standard Deviation 42.2789	—	—	—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	171.355 hours*mm Standard Deviation 394.6735	180.875 hours*mm Standard Deviation 212.9759	380.602 hours*mm Standard Deviation 261.1626	26.844 hours*mm Standard Deviation 101.2648	148.883 hours*mm Standard Deviation 183.8413	297.844 hours*mm Standard Deviation 240.6209	—	—	—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	5.254 hours*mm Standard Deviation 12.3129	28.234 hours*mm Standard Deviation 25.4785	44.656 hours*mm Standard Deviation 19.3060	0.805 hours*mm Standard Deviation 3.6598	20.727 hours*mm Standard Deviation 23.7958	40.992 hours*mm Standard Deviation 19.3835	—	—	—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	40.418 hours*mm Standard Deviation 87.9945	159.750 hours*mm Standard Deviation 156.8189	332.352 hours*mm Standard Deviation 193.5146	9.063 hours*mm Standard Deviation 24.0659	130.758 hours*mm Standard Deviation 152.6257	261.813 hours*mm Standard Deviation 163.8714	—	—	—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	77.855 hours*mm Standard Deviation 172.2503	168.688 hours*mm Standard Deviation 173.4909	372.414 hours*mm Standard Deviation 248.2861	9.250 hours*mm Standard Deviation 24.0378	148.195 hours*mm Standard Deviation 183.1627	282.875 hours*mm Standard Deviation 205.0344	—	—	—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	161.043 hours*mm Standard Deviation 349.4292	180.875 hours*mm Standard Deviation 212.9759	380.414 hours*mm Standard Deviation 261.0990	17.469 hours*mm Standard Deviation 51.3009	148.883 hours*mm Standard Deviation 183.8413	297.656 hours*mm Standard Deviation 240.6821	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.517 hours Interval 0.25 to 14.02	1.017 hours Interval 0.25 to 8.03	1.017 hours Interval 0.48 to 4.02	0.258 hours Interval 0.25 to 24.02	1.017 hours Interval 0.25 to 8.0	1.017 hours Interval 0.27 to 4.0	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Bad Drug Effects: Peak Effect (Emax)	20.6 mm Standard Deviation 35.67	16.9 mm Standard Deviation 28.85	31.4 mm Standard Deviation 32.67	5.8 mm Standard Deviation 15.46	16.4 mm Standard Deviation 26.76	26.5 mm Standard Deviation 36.60	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	0.445 hours*mm Standard Deviation 2.4294	0.918 hours*mm Standard Deviation 2.4707	3.621 hours*mm Standard Deviation 7.2682	0.652 hours*mm Standard Deviation 3.5995	0.977 hours*mm Standard Deviation 2.9225	4.359 hours*mm Standard Deviation 12.9297	—	—	—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	2.359 hours*mm Standard Deviation 8.9454	4.840 hours*mm Standard Deviation 10.9280	17.059 hours*mm Standard Deviation 28.6213	1.270 hours*mm Standard Deviation 5.2494	8.164 hours*mm Standard Deviation 18.3516	16.023 hours*mm Standard Deviation 32.3331	—	—	—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	22.195 hours*mm Standard Deviation 63.1674	38.191 hours*mm Standard Deviation 83.7177	81.777 hours*mm Standard Deviation 124.7723	2.527 hours*mm Standard Deviation 7.6234	28.984 hours*mm Standard Deviation 47.6235	60.133 hours*mm Standard Deviation 104.8279	—	—	—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	41.570 hours*mm Standard Deviation 88.3012	46.691 hours*mm Standard Deviation 105.0132	96.715 hours*mm Standard Deviation 157.0901	2.527 hours*mm Standard Deviation 7.6234	29.984 hours*mm Standard Deviation 48.2808	71.195 hours*mm Standard Deviation 112.5641	—	—	—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	138.039 hours*mm Standard Deviation 300.2416	50.348 hours*mm Standard Deviation 111.5406	102.434 hours*mm Standard Deviation 167.6105	10.340 hours*mm Standard Deviation 44.8420	30.203 hours*mm Standard Deviation 48.4810	85.477 hours*mm Standard Deviation 145.5365	—	—	—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	169.352 hours*mm Standard Deviation 379.2034	51.473 hours*mm Standard Deviation 113.3471	102.621 hours*mm Standard Deviation 167.6904	19.715 hours*mm Standard Deviation 97.5206	30.578 hours*mm Standard Deviation 48.6353	85.852 hours*mm Standard Deviation 146.1250	—	—	—

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)	0.308 hours Interval 0.25 to 36.02	0.267 hours Interval 0.25 to 12.02	1.758 hours Interval 0.23 to 8.03	0.250 hours Interval 0.25 to 24.02	0.267 hours Interval 0.23 to 5.02	1.517 hours Interval 0.25 to 24.02	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Feel Sick: Peak Effect (Emax)	10.1 mm Standard Deviation 26.35	2.6 mm Standard Deviation 7.06	11.7 mm Standard Deviation 28.16	3.1 mm Standard Deviation 10.80	5.4 mm Standard Deviation 15.14	8.8 mm Standard Deviation 25.63	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	0.035 hours*mm Standard Deviation 0.1463	0.039 hours*mm Standard Deviation 0.1435	0.996 hours*mm Standard Deviation 3.2217	0.539 hours*mm Standard Deviation 3.0494	0.629 hours*mm Standard Deviation 3.0605	0.957 hours*mm Standard Deviation 3.3182	—	—	—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	1.051 hours*mm Standard Deviation 4.5067	0.758 hours*mm Standard Deviation 2.6560	2.762 hours*mm Standard Deviation 6.8438	0.727 hours*mm Standard Deviation 4.0198	3.004 hours*mm Standard Deviation 14.4372	4.160 hours*mm Standard Deviation 16.6354	—	—	—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	12.324 hours*mm Standard Deviation 61.4559	5.281 hours*mm Standard Deviation 17.1483	15.449 hours*mm Standard Deviation 36.7603	0.984 hours*mm Standard Deviation 4.2307	5.176 hours*mm Standard Deviation 17.2686	13.387 hours*mm Standard Deviation 40.8525	—	—	—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	12.949 hours*mm Standard Deviation 63.8914	6.156 hours*mm Standard Deviation 19.8004	19.137 hours*mm Standard Deviation 42.3860	0.984 hours*mm Standard Deviation 4.2307	5.176 hours*mm Standard Deviation 17.2686	13.387 hours*mm Standard Deviation 40.8525	—	—	—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	64.699 hours*mm Standard Deviation 196.3450	7.406 hours*mm Standard Deviation 22.7994	19.605 hours*mm Standard Deviation 42.5054	8.797 hours*mm Standard Deviation 44.3081	5.645 hours*mm Standard Deviation 18.1099	13.387 hours*mm Standard Deviation 40.8525	—	—	—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	83.449 hours*mm Standard Deviation 267.7102	7.594 hours*mm Standard Deviation 22.9559	21.855 hours*mm Standard Deviation 43.9416	18.359 hours*mm Standard Deviation 97.2004	6.582 hours*mm Standard Deviation 19.7796	13.387 hours*mm Standard Deviation 40.8525	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Feel Sick: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 24.05	0.267 hours Interval 0.25 to 12.02	0.267 hours Interval 0.23 to 24.0	0.250 hours Interval 0.25 to 36.0	0.267 hours Interval 0.23 to 24.0	0.267 hours Interval 0.25 to 3.03	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Nausea: Peak Effect (Emax)	9.5 mm Standard Deviation 26.18	11.3 mm Standard Deviation 23.47	22.0 mm Standard Deviation 33.25	6.1 mm Standard Deviation 18.90	11.5 mm Standard Deviation 25.07	17.8 mm Standard Deviation 32.11	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	0.043 hours*mm Standard Deviation 0.1510	0.281 hours*mm Standard Deviation 1.0395	2.797 hours*mm Standard Deviation 8.7018	1.551 hours*mm Standard Deviation 8.7270	1.313 hours*mm Standard Deviation 4.2183	3.867 hours*mm Standard Deviation 13.3986	—	—	—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	0.520 hours*mm Standard Deviation 2.3602	3.813 hours*mm Standard Deviation 11.0316	9.398 hours*mm Standard Deviation 19.9006	3.309 hours*mm Standard Deviation 16.0847	6.938 hours*mm Standard Deviation 18.5123	11.500 hours*mm Standard Deviation 30.7880	—	—	—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	12.465 hours*mm Standard Deviation 46.6764	15.453 hours*mm Standard Deviation 33.4096	39.648 hours*mm Standard Deviation 75.0136	5.801 hours*mm Standard Deviation 21.1576	17.656 hours*mm Standard Deviation 40.3906	34.102 hours*mm Standard Deviation 88.7640	—	—	—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	16.340 hours*mm Standard Deviation 58.2244	18.828 hours*mm Standard Deviation 41.2148	41.523 hours*mm Standard Deviation 78.2852	5.801 hours*mm Standard Deviation 21.1576	17.656 hours*mm Standard Deviation 40.3906	40.602 hours*mm Standard Deviation 97.6330	—	—	—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	76.402 hours*mm Standard Deviation 243.7336	21.203 hours*mm Standard Deviation 45.1793	42.992 hours*mm Standard Deviation 80.0147	13.613 hours*mm Standard Deviation 54.7055	17.656 hours*mm Standard Deviation 40.3906	52.508 hours*mm Standard Deviation 132.8214	—	—	—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	94.777 hours*mm Standard Deviation 325.6554	21.391 hours*mm Standard Deviation 45.4013	43.742 hours*mm Standard Deviation 79.9894	22.988 hours*mm Standard Deviation 105.8442	17.844 hours*mm Standard Deviation 40.3199	52.508 hours*mm Standard Deviation 132.8214	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Nausea: Time to Maximum (Peak) Effect (TEmax)	0.267 hours Interval 0.25 to 36.02	0.267 hours Interval 0.25 to 12.02	0.267 hours Interval 0.23 to 6.0	0.250 hours Interval 0.25 to 5.0	0.267 hours Interval 0.25 to 36.0	0.267 hours Interval 0.25 to 12.02	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Sleepy: Peak Effect (Emax)	38.3 mm Standard Deviation 38.32	59.2 mm Standard Deviation 36.76	76.1 mm Standard Deviation 25.88	24.7 mm Standard Deviation 34.06	56.8 mm Standard Deviation 35.54	72.0 mm Standard Deviation 30.57	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	9.004 hours*mm Standard Deviation 18.9625	10.789 hours*mm Standard Deviation 17.0139	22.590 hours*mm Standard Deviation 19.7659	3.660 hours*mm Standard Deviation 11.1947	9.160 hours*mm Standard Deviation 12.4734	17.555 hours*mm Standard Deviation 18.6009	—	—	—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	27.512 hours*mm Standard Deviation 43.9712	49.125 hours*mm Standard Deviation 49.5132	79.848 hours*mm Standard Deviation 46.1185	17.809 hours*mm Standard Deviation 35.0786	44.152 hours*mm Standard Deviation 38.4132	66.906 hours*mm Standard Deviation 46.9339	—	—	—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	127.855 hours*mm Standard Deviation 188.5158	223.984 hours*mm Standard Deviation 196.8453	378.309 hours*mm Standard Deviation 195.1978	57.035 hours*mm Standard Deviation 117.1422	196.691 hours*mm Standard Deviation 178.5590	295.727 hours*mm Standard Deviation 204.5401	—	—	—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	195.418 hours*mm Standard Deviation 271.9999	270.109 hours*mm Standard Deviation 253.5547	440.809 hours*mm Standard Deviation 232.3446	68.785 hours*mm Standard Deviation 151.3384	239.566 hours*mm Standard Deviation 244.9626	352.289 hours*mm Standard Deviation 260.5164	—	—	—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	346.949 hours*mm Standard Deviation 494.5935	341.922 hours*mm Standard Deviation 407.7011	487.559 hours*mm Standard Deviation 284.8306	107.254 hours*mm Standard Deviation 299.1972	295.941 hours*mm Standard Deviation 314.6515	407.820 hours*mm Standard Deviation 342.4604	—	—	—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	382.012 hours*mm Standard Deviation 585.0876	362.922 hours*mm Standard Deviation 486.0190	493.559 hours*mm Standard Deviation 290.1531	135.941 hours*mm Standard Deviation 402.8944	299.316 hours*mm Standard Deviation 316.1870	414.008 hours*mm Standard Deviation 349.3465	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Sleepy: Time to Maximum (Peak) Effect (TEmax)	2.000 hours Interval 0.25 to 14.03	2.017 hours Interval 0.27 to 12.02	2.033 hours Interval 0.52 to 6.02	0.758 hours Interval 0.25 to 24.02	2.025 hours Interval 0.25 to 12.0	2.508 hours Interval 0.25 to 12.02	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Dizzy: Peak Effect (Emax)	12.0 mm Standard Deviation 28.21	19.5 mm Standard Deviation 31.56	39.3 mm Standard Deviation 37.92	3.6 mm Standard Deviation 12.27	23.4 mm Standard Deviation 32.63	30.6 mm Standard Deviation 36.58	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	23.934 hours*mm Standard Deviation 82.1109	41.410 hours*mm Standard Deviation 79.0200	117.738 hours*mm Standard Deviation 146.9677	1.844 hours*mm Standard Deviation 6.2523	47.297 hours*mm Standard Deviation 82.8121	75.828 hours*mm Standard Deviation 117.4212	—	—	—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	1.238 hours*mm Standard Deviation 4.8747	6.207 hours*mm Standard Deviation 12.4631	14.043 hours*mm Standard Deviation 17.1328	0.125 hours*mm Standard Deviation 0.5425	7.117 hours*mm Standard Deviation 15.3098	10.117 hours*mm Standard Deviation 15.9090	—	—	—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	2.738 hours*mm Standard Deviation 10.8592	18.402 hours*mm Standard Deviation 33.2777	35.691 hours*mm Standard Deviation 44.1487	0.922 hours*mm Standard Deviation 3.0851	24.008 hours*mm Standard Deviation 41.3549	28.758 hours*mm Standard Deviation 39.5123	—	—	—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	47.684 hours*mm Standard Deviation 145.0991	42.160 hours*mm Standard Deviation 79.5674	122.551 hours*mm Standard Deviation 150.8804	1.906 hours*mm Standard Deviation 6.2536	48.422 hours*mm Standard Deviation 85.1544	83.266 hours*mm Standard Deviation 131.6787	—	—	—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	120.934 hours*mm Standard Deviation 324.0852	43.754 hours*mm Standard Deviation 81.6192	122.895 hours*mm Standard Deviation 150.6660	10.094 hours*mm Standard Deviation 49.8279	49.922 hours*mm Standard Deviation 88.2865	85.484 hours*mm Standard Deviation 136.4813	—	—	—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	135.559 hours*mm Standard Deviation 386.0688	44.129 hours*mm Standard Deviation 81.4783	123.457 hours*mm Standard Deviation 150.3432	19.844 hours*mm Standard Deviation 102.7158	50.109 hours*mm Standard Deviation 88.1834	85.859 hours*mm Standard Deviation 136.2835	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Dizzy: Time to Maximum (Peak) Effect (TEmax)	0.258 hours Interval 0.25 to 14.02	0.292 hours Interval 0.25 to 13.98	0.758 hours Interval 0.23 to 8.03	0.250 hours Interval 0.25 to 8.0	0.758 hours Interval 0.25 to 36.02	0.767 hours Interval 0.25 to 24.02	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.

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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Pupillometry: Peak Effect (Emax)	-2.4 mm Standard Deviation 0.71	-2.1 mm Standard Deviation 0.63	-3.0 mm Standard Deviation 0.76	-0.8 mm Standard Deviation 0.38	-2.0 mm Standard Deviation 0.71	-2.7 mm Standard Deviation 0.72	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.

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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	33.605 hours*mm Standard Deviation 6.4972	29.298 hours*mm Standard Deviation 5.4769	21.913 hours*mm Standard Deviation 3.6297	41.088 hours*mm Standard Deviation 6.4135	30.129 hours*mm Standard Deviation 5.7346	23.795 hours*mm Standard Deviation 4.0637	—	—	—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	130.199 hours*mm Standard Deviation 23.0719	161.977 hours*mm Standard Deviation 26.8529	141.638 hours*mm Standard Deviation 28.1687	188.828 hours*mm Standard Deviation 29.4183	162.961 hours*mm Standard Deviation 29.2071	149.454 hours*mm Standard Deviation 25.4599	—	—	—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	5.039 hours*mm Standard Deviation 0.7893	3.986 hours*mm Standard Deviation 0.6847	3.489 hours*mm Standard Deviation 0.6738	5.160 hours*mm Standard Deviation 0.7979	4.022 hours*mm Standard Deviation 0.7658	3.599 hours*mm Standard Deviation 0.6554	—	—	—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-2)	9.889 hours*mm Standard Deviation 1.6078	7.384 hours*mm Standard Deviation 1.2278	5.927 hours*mm Standard Deviation 1.0310	10.164 hours*mm Standard Deviation 1.5890	7.564 hours*mm Standard Deviation 1.3695	6.226 hours*mm Standard Deviation 1.0741	—	—	—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	46.155 hours*mm Standard Deviation 8.8631	46.136 hours*mm Standard Deviation 8.9456	35.088 hours*mm Standard Deviation 6.4060	62.550 hours*mm Standard Deviation 9.6352	47.586 hours*mm Standard Deviation 9.5615	38.713 hours*mm Standard Deviation 7.6202	—	—	—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	83.530 hours*mm Standard Deviation 14.6930	102.183 hours*mm Standard Deviation 17.7741	83.832 hours*mm Standard Deviation 17.6410	125.791 hours*mm Standard Deviation 19.2063	103.711 hours*mm Standard Deviation 19.5429	91.216 hours*mm Standard Deviation 17.4729	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.

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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Pupillometry: Time to Maximum (Peak) Effect (TEmax)	12.050 hours Interval 5.0 to 14.03	1.775 hours Interval 0.52 to 5.02	1.533 hours Interval 0.5 to 6.02	2.275 hours Interval 0.52 to 36.02	1.517 hours Interval 0.52 to 6.02	1.517 hours Interval 0.53 to 5.02	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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.

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

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=38 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone (n= 36, 37, 38, 37, 36)	0.583 hours Interval 0.533 to 1.55	1.04 hours Interval 0.3 to 2.55	—	1.03 hours Interval 0.533 to 2.55	1.03 hours Interval 0.283 to 3.07	12.1 hours Interval 3.03 to 14.1	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone (n= 36, 36, 37, 37, 35)	0.567 hours Interval 0.3 to 1.07	0.550 hours Interval 0.3 to 2.55	—	0.559 hours Interval 0.3 to 1.58	0.567 hours Interval 0.283 to 3.07	14.0 hours Interval 8.07 to 24.1	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone (n= 36, 37, 38, 37, 36)	0.600 hours Interval 0.533 to 3.08	1.05 hours Interval 0.3 to 5.03	—	1.03 hours Interval 0.533 to 3.03	1.07 hours Interval 0.533 to 3.07	14.1 hours Interval 3.03 to 24.1	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	50.703 hours*mm Standard Deviation 3.2294	61.125 hours*mm Standard Deviation 12.7119	69.734 hours*mm Standard Deviation 12.6273	50.020 hours*mm Standard Deviation 2.7443	57.770 hours*mm Standard Deviation 11.2102	64.820 hours*mm Standard Deviation 14.3058	—	—	—
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	404.578 hours*mm Standard Deviation 71.1457	465.945 hours*mm Standard Deviation 110.9382	531.586 hours*mm Standard Deviation 110.7145	399.957 hours*mm Standard Deviation 8.2973	431.973 hours*mm Standard Deviation 80.0157	492.578 hours*mm Standard Deviation 112.1774	—	—	—
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	1203.828 hours*mm Standard Deviation 289.3240	1285.289 hours*mm Standard Deviation 209.4193	1398.836 hours*mm Standard Deviation 237.2094	1202.863 hours*mm Standard Deviation 9.1566	1267.410 hours*mm Standard Deviation 197.1640	1337.016 hours*mm Standard Deviation 241.1654	—	—	—
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	616.203 hours*mm Standard Deviation 130.7196	677.320 hours*mm Standard Deviation 147.0075	758.336 hours*mm Standard Deviation 160.5459	600.645 hours*mm Standard Deviation 8.1980	640.223 hours*mm Standard Deviation 111.0897	704.328 hours*mm Standard Deviation 140.9602	—	—	—
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	1783.578 hours*mm Standard Deviation 361.8779	1907.414 hours*mm Standard Deviation 310.0402	2024.711 hours*mm Standard Deviation 347.2035	1805.113 hours*mm Standard Deviation 11.7017	1893.848 hours*mm Standard Deviation 298.9190	1955.953 hours*mm Standard Deviation 326.5777	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Drug Liking: Time to Maximum (Peak) Effect (TEmax)	0.758 hours Interval 0.25 to 14.02	1.017 hours Interval 0.25 to 24.02	1.008 hours Interval 0.25 to 24.02	0.267 hours Interval 0.25 to 5.02	1.017 hours Interval 0.25 to 24.02	1.017 hours Interval 0.27 to 14.02	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-24)	161.613 hours*mm Standard Deviation 319.3473	171.129 hours*mm Standard Deviation 180.2282	362.531 hours*mm Standard Deviation 252.5074	24.199 hours*mm Standard Deviation 69.6362	131.930 hours*mm Standard Deviation 168.8668	282.902 hours*mm Standard Deviation 215.7112	—	—	—
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-1)	4.473 hours*mm Standard Deviation 11.7536	27.465 hours*mm Standard Deviation 24.2206	45.836 hours*mm Standard Deviation 20.4802	0.785 hours*mm Standard Deviation 4.1738	20.203 hours*mm Standard Deviation 22.8004	40.801 hours*mm Standard Deviation 20.3235	—	—	—
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-8)	39.145 hours*mm Standard Deviation 85.5494	153.941 hours*mm Standard Deviation 150.3297	322.250 hours*mm Standard Deviation 187.7896	6.512 hours*mm Standard Deviation 16.7072	119.055 hours*mm Standard Deviation 142.3080	257.527 hours*mm Standard Deviation 163.9543	—	—	—
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-12)	78.582 hours*mm Standard Deviation 166.6578	160.004 hours*mm Standard Deviation 160.4458	355.250 hours*mm Standard Deviation 237.6863	6.512 hours*mm Standard Deviation 16.7072	131.805 hours*mm Standard Deviation 168.5472	277.715 hours*mm Standard Deviation 201.6860	—	—	—
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour AUE (0-36)	168.176 hours*mm Standard Deviation 337.3448	173.379 hours*mm Standard Deviation 181.7041	362.531 hours*mm Standard Deviation 252.5074	34.137 hours*mm Standard Deviation 110.6283	132.305 hours*mm Standard Deviation 170.0009	282.902 hours*mm Standard Deviation 215.7112	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Population: Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
High: Time to Maximum (Peak) Effect (TEmax)	0.767 hours Interval 0.25 to 14.03	1.017 hours Interval 0.25 to 8.03	1.017 hours Interval 0.48 to 3.03	0.250 hours Interval 0.25 to 24.02	1.017 hours Interval 0.25 to 6.0	1.017 hours Interval 0.27 to 4.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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. Here 'n' signifies those participants who were evaluable for specified category.

Cmax[dn]=Dose normalized maximum observed plasma concentration of participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=38 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone Oxycodone (n= 36, 37, 38, 37, 36)	1.923 nanogram/milliliter/milligram Standard Deviation 0.54296	1.514 nanogram/milliliter/milligram Standard Deviation 0.42099	—	1.989 nanogram/milliliter/milligram Standard Deviation 0.62042	1.672 nanogram/milliliter/milligram Standard Deviation 0.40716	0.4978 nanogram/milliliter/milligram Standard Deviation 0.15863	—	—	—
Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone Oxymorphone (n= 36, 36, 38, 37, 35)	0.03182 nanogram/milliliter/milligram Standard Deviation 0.0161	0.02419 nanogram/milliliter/milligram Standard Deviation 0.0118	—	0.03271 nanogram/milliliter/milligram Standard Deviation 0.0155	0.02847 nanogram/milliliter/milligram Standard Deviation 0.0149	0.0068 nanogram/milliliter/milligram Standard Deviation 0.00365	—	—	—
Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone Noroxycodone (n= 36, 37, 38, 37, 36)	1.343 nanogram/milliliter/milligram Standard Deviation 0.36175	1.026 nanogram/milliliter/milligram Standard Deviation 0.33231	—	1.295 nanogram/milliliter/milligram Standard Deviation 0.37231	1.123 nanogram/milliliter/milligram Standard Deviation 0.29543	0.3672 nanogram/milliliter/milligram Standard Deviation 0.18111	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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

Measure	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=38 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=37 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol Naltrexone	—	—	—	1.389 nanogram per milliliter (ng/mL) Standard Deviation 1.4633	0.01808 nanogram per milliliter (ng/mL) Standard Deviation 0.11145	2.331 nanogram per milliliter (ng/mL) Standard Deviation 2.4498	—	—	—
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol 6-beta-naltrexol	—	—	—	8.516 nanogram per milliliter (ng/mL) Standard Deviation 2.4847	0.3012 nanogram per milliliter (ng/mL) Standard Deviation 1.8325	13.70 nanogram per milliliter (ng/mL) Standard Deviation 3.1369	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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.

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

Outcome measures

Measure	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=38 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=37 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol 6-beta-naltrexol (n= 36, 19, 37)	—	—	—	0.567 hour Interval 0.367 to 2.55	1.55 hour Interval 0.0 to 36.1	0.550 hour Interval 0.283 to 1.55	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol Naltrexone (n= 36, 1, 37)	—	—	—	0.550 hour Interval 0.283 to 1.58	1.58 hour Interval 1.58 to 1.58	0.550 hour Interval 0.283 to 1.07	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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' (number of participants analyzed) signifies those participants evaluable for this measure.

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

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=35 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Plasma Terminal Half-Life (t1/2) of Oxycodone	4.300 hours Interval 3.02 to 5.81	4.195 hours Interval 3.2 to 5.35	—	4.470 hours Interval 3.14 to 5.82	4.240 hours Interval 3.07 to 5.91	9.340 hours Interval 5.67 to 12.4	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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 were reported.

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=38 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone AUC (0-2)	157.5 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 37.317	120.0 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 34.767	—	103.5 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 29.463	88.12 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 20.159	0.7834 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 0.42296	—	—	—
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone AUC (0-12)	464.8 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 121.19	451.5 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 116.62	—	319.6 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 87.905	314.1 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 72.753	181.6 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 43.706	—	—	—
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone AUC (0-24)	513.9 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 143.01	527.8 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 149.84	—	356.2 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 104.68	355.9 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 91.851	455.3 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 118.50	—	—	—
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone AUC (0-1)	72.25 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 24.141	53.38 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 19.223	—	45.21 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 19.256	37.60 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 13.292	0.02102 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 0.05715	—	—	—
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone AUC (0-8)	405.5 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 98.993	366.5 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 88.598	—	276.8 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 72.686	265.0 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 55.929	79.08 nanogram*hour/milliliter (ng*hr/mL) Standard Deviation 19.900	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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 were reported.

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=38 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone	521.0 ng*hr/mL Standard Deviation 147.32	538.6 ng*hr/mL Standard Deviation 155.71	—	361.6 ng*hr/mL Standard Deviation 108.39	361.6 ng*hr/mL Standard Deviation 95.617	575.8 ng*hr/mL Standard Deviation 150.15	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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' (number of participants analyzed) signifies those participants evaluable for this measure.

[AUC (0 - ∞)dn]= Dose normalized area under the plasma concentration versus time curve [AUC(dn)] from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0- t) plus AUC (t - ∞). Participants who received oxycodone were reported. Participants who received oxycodone were reported.

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=36 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=37 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=35 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone	8.718 ng*hr/mL/mg Standard Deviation 2.4635	9.018 ng*hr/mL/mg Standard Deviation 2.6095	—	9.079 ng*hr/mL/mg Standard Deviation 2.7120	9.085 ng*hr/mL/mg Standard Deviation 2.3977	10.88 ng*hr/mL/mg Standard Deviation 2.9327	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening up to 28 days after last study drug administration (Day 29)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

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. 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

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=37 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=75 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=72 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=69 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=38 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=37 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=36 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	12 participants	29 participants	37 participants	5 participants	70 participants	14 participants	27 participants	34 participants	36 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening up to 7 days following last study drug administration (Day 8)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, respiratory rate and oral temperature. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.

Outcome measures

Measure	ALO-02 60 Mg-I n=37 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=36 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=37 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=75 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=72 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=69 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=38 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=37 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=36 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth 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	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5 hours post-dose in drug discrimination phase; pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in intervention period

Population: Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in "Naloxone Challenge Phase", as pre-specified in protocol.

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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=72 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=69 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period

Population: Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in "Naloxone Challenge Phase", as pre-specified in protocol.

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 measurements was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator might had 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

Measure	ALO-02 60 Mg-I n=32 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=32 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=32 Participants Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo n=32 Participants Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=32 Participants Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=32 Participants Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=72 Participants Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 mg- C n=69 Participants Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth 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	0 participants	0 participants	—

Adverse Events

Naloxone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Oxycodone HCl 40 mg

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ALO-02 40 Mg-C

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

OXY 40 mg

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

ALO-02 60 Mg-I

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

ALO-02 60 Mg-C

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

OXY 60 mg

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo Oxycodone HCl

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Naloxone n=75 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 40 mg n=72 participants at risk Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase.	Placebo n=37 participants at risk Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=36 participants at risk Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=37 participants at risk Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=38 participants at risk Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-C n=37 participants at risk Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=36 participants at risk Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo Oxycodone HCl n=69 participants at risk Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase.
Cardiac disorders Sinus arrest	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Naloxone n=75 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 40 mg n=72 participants at risk Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase.	Placebo n=37 participants at risk Single dose of matching placebo solution orally in either of the first to sixth intervention periods.	ALO-02 40 Mg-C n=36 participants at risk Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 40 mg n=37 participants at risk Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-I n=38 participants at risk Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.	ALO-02 60 Mg-C n=37 participants at risk Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.	OXY 60 mg n=36 participants at risk Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.	Placebo Oxycodone HCl n=69 participants at risk Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase.
Gastrointestinal disorders Dry mouth	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	19.4% 14/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.8% 4/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.1% 3/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.9% 5/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.1% 13/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.1% 3/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.1% 4/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.2% 6/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.2% 5/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.2% 6/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	19.4% 7/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 4/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.4% 2/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.3% 2/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.1% 4/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.8% 2/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 2/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.5% 5/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.5% 4/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.8% 4/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.1% 4/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 3/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Feeling hot	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.3% 11/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 2/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.5% 5/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.9% 7/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 2/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Feeling of relaxation	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 3/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.8% 1/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.4% 2/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.8% 1/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 2/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.9% 10/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 6/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	21.6% 8/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.4% 7/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.9% 7/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	27.8% 10/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 2/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.4% 2/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.8% 1/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.8% 4/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	18.4% 7/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.5% 5/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.1% 4/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	29.2% 21/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.8% 4/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	38.9% 14/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	35.1% 13/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	26.3% 10/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	37.8% 14/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	47.2% 17/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.8% 4/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Euphoric mood	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	76.4% 55/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	52.8% 19/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	83.8% 31/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	28.9% 11/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	62.2% 23/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	86.1% 31/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hypervigilance	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.6% 2/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.9% 5/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.7% 1/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 3/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	48.6% 35/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	13.9% 5/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	48.6% 18/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	36.8% 14/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	21.6% 8/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	66.7% 24/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus generalised	1.3% 1/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 6/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.8% 1/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.8% 4/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.6% 1/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 3/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	0.00% 0/75 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/72 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.4% 2/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/38 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/37 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/36 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/69 • Baseline up to 28 days after last study drug administration (Day 29) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

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.
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Restriction type: OTHER