Trial Outcomes & Findings for Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. (NCT NCT00801398)

NCT ID: NCT00801398

Last Updated: 2019-02-27

Results Overview

Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 58 participants
• Primary outcome timeframe: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
• Results posted on: 2019-02-27

Participant Flow

Participant milestones

Measure	Single Dose of Oxymorphone IR: 5mg Tablet	Single Dose of Oxymorphone IR: 10mg Tablet	Single Dose of Oxymorphone IR: 15mg Tablet	Multiple Dose of Oxymorphone: 5mg Tablet	Multiple Dose of Oxymorphone IR: 10mg Tablet	Multiple Dose of Oxymorphone IR: 15mg Tablet
Overall Study STARTED	13	9	11	9	8	8
Overall Study COMPLETED	7	0	4	3	1	5
Overall Study NOT COMPLETED	6	9	7	6	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)

Baseline characteristics by cohort

Measure	Single Dose of Oxymorphone IR: 5mg Tablet n=13 Participants	Single Dose of Oxymorphone IR: 10mg Tablet n=9 Participants	Single Dose of Oxymorphone IR: 15mg Tablet n=11 Participants	Multiple Dose of Oxymorphone IR: 5mg Tablet n=9 Participants	Multiple Dose of Oxymorphone IR: 10mg Tablet n=8 Participants	Multiple Dose of Oxymorphone IR: 15mg Tablet n=8 Participants	Total n=58 Participants Total of all reporting groups
Age, Continuous	14.9 years STANDARD_DEVIATION 1.71 • n=5 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	15.3 years STANDARD_DEVIATION 1.66 • n=7 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	14.6 years STANDARD_DEVIATION 1.63 • n=5 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	15.0 years STANDARD_DEVIATION 0.71 • n=4 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	15.3 years STANDARD_DEVIATION 1.58 • n=21 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	15.5 years STANDARD_DEVIATION 1.07 • n=8 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)	15.07 years STANDARD_DEVIATION 1.44 • n=8 Participants • Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13)
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=8 Participants	38 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	20 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	55 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=8 Participants	50 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment United States	13 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	58 Participants n=8 Participants

PRIMARY outcome

Timeframe: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination

Population: ITT Population

Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=13 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=11 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=8 Participants Change from Baseline
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Early Termination	—	—	—	1.8 mm Standard Deviation 50.74	7.4 mm Standard Deviation 42.29	—
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 15 Minutes Post Dose/ 15 Minutes Post First Dose	-13.4 mm Standard Deviation 22.86	-22.2 mm Standard Deviation 17.79	-21.6 mm Standard Deviation 13.59	-16.7 mm Standard Deviation 23.31	0.5 mm Standard Deviation 9.56	-17.4 mm Standard Deviation 13.46
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 30 Minutes Post Dose/30 Minutes Post First Dose	-12.8 mm Standard Deviation 36.90	-13.7 mm Standard Deviation 28.32	-22.9 mm Standard Deviation 19.87	-18.3 mm Standard Deviation 25.84	3.1 mm Standard Deviation 22.33	-23.0 mm Standard Deviation 15.94
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 1 Hour Post Dose/1 Hour Post First Dose	-24.70 mm Standard Deviation 36.74	-17.4 mm Standard Deviation 28.64	-29.8 mm Standard Deviation 20.02	-22.0 mm Standard Deviation 25.13	-7.8 mm Standard Deviation 18.90	-28.3 mm Standard Deviation 15.00
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 2 Hours Post Dose/2 Hours Post First Dose	-19.3 mm Standard Deviation 29.07	-29.0 mm Standard Deviation 25.55	-33.8 mm Standard Deviation 20.10	-14.4 mm Standard Deviation 36.56	-6.3 mm Standard Deviation 22.04	-12.9 mm Standard Deviation 34.37
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 3 Hours Post Dose/3 Hours Post First Dose	-35.4 mm Standard Deviation 26.97	-29.3 mm Standard Deviation 20.21	-28.6 mm Standard Deviation 16.75	-25.8 mm Standard Deviation 40.17	-15.5 mm Standard Deviation 19.67	-24.7 mm Standard Deviation 20.70
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 4 Hours Post Dose/4 Hours Post First Dose	-36.2 mm Standard Deviation 25.03	-19.5 mm Standard Deviation 45.96	-31.5 mm Standard Deviation 14.20	-34.8 mm Standard Deviation 31.65	-7.5 mm Standard Deviation 29.33	-10.8 mm Standard Deviation 20.64
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet 6 Hrs Post Dose or Rescue/6 Hours Post First Dose	-34.4 mm Standard Deviation 25.32	-3.0 mm Standard Deviation 21.85	-18.2 mm Standard Deviation 18.73	-41.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-6.0 mm Standard Deviation 20.22	-38.3 mm Standard Deviation 9.45
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #1	—	—	—	-28.0 mm Standard Deviation 14.11	-15.0 mm Standard Deviation 17.72	-25.2 mm Standard Deviation 11.65
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #2	—	—	—	-33.5 mm Standard Deviation 10.61	0.8 mm Standard Deviation 7.04	-17.6 mm Standard Deviation 20.70
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #3	—	—	—	-33.5 mm Standard Deviation 10.61	4.0 mm Standard Deviation 18.38	-26.4 mm Standard Deviation 12.38
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #4	—	—	—	-33.0 mm Standard Deviation 11.31	18.5 mm Standard Deviation 13.44	-25.4 mm Standard Deviation 4.04
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #5	—	—	—	-38.0 mm Standard Deviation 4.24	-19.0 mm Standard Deviation 41.01	-21.6 mm Standard Deviation 19.03
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #6	—	—	—	-38.0 mm Standard Deviation 4.24	-1.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-32.8 mm Standard Deviation 15.32
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #7	—	—	—	-33.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-36.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-26.6 mm Standard Deviation 21.80
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #8	—	—	—	-35.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-8.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-32.7 mm Standard Deviation 13.65
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #9	—	—	—	-34.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-6.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-22.7 mm Standard Deviation 15.50
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #10	—	—	—	—	-6.0 mm	-29.0 mm Standard Deviation 17.06
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet Multiple Dose #11	—	—	—	—	-29.0 mm Standard Deviation NA SD cannot be derived based on one subject data point	-17.0 mm Standard Deviation NA SD cannot be derived based on one subject data point

PRIMARY outcome

Timeframe: first dose through 48 hours after first dose

Population: Safety Population

Percentages are based on the number of subjects in each treatment group.

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=13 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=11 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=8 Participants Change from Baseline
Subjects Taking Rescue Medication	9 Participants	9 Participants	7 Participants	5 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
AUC(0-t) of Single Dose of Oxymorphone by Treatment Group	6.395 ng*hr/mL Standard Deviation 6.0752	3.766 ng*hr/mL Standard Deviation 2.2587	67.040 ng*hr/mL Standard Deviation 150.7979	1.544 ng*hr/mL Standard Deviation 1.8794	3.040 ng*hr/mL Standard Deviation 1.1625	7.354 ng*hr/mL Standard Deviation 3.3255

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=3 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group	7.632 ng*hr/mL Standard Deviation 6.6828	10.223 ng*hr/mL Standard Deviation 6.5195	109.294 ng*hr/mL Standard Deviation 257.5421	4.987 ng*hr/mL Standard Deviation 7.5732	8.692 ng*hr/mL Standard Deviation 10.2430	12.795 ng*hr/mL Standard Deviation 8.8385

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
Cmax of Single Dose of Oxymorphone by Treatment Group	1.243 ng/mL Standard Deviation 1.2192	0.828 ng/mL Standard Deviation 0.6892	5.295 ng/mL Standard Deviation 10.6386	0.314 ng/mL Standard Deviation 0.3276	0.487 ng/mL Standard Deviation 0.2853	0.940 ng/mL Standard Deviation 0.5212

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Tmax: The time at which Cmax was observed

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=6 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
Tmax of Single Dose of Oxymorphone by Treatment Group	4.898 hour Standard Deviation 3.9645	3.681 hour Standard Deviation 2.4102	6.193 hour Standard Deviation 6.3784	3.885 hour Standard Deviation 2.7228	4.631 hour Standard Deviation 3.7051	3.785 hour Standard Deviation 3.2552

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=3 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group	0.209 Time -1 Standard Deviation 0.2552	0.214 Time -1 Standard Deviation 0.2962	0.073 Time -1 Standard Deviation 0.0549	0.281 Time -1 Standard Deviation 0.2072	0.101 Time -1 Standard Deviation 0.0965	0.042 Time -1 Standard Deviation 0.0234

SECONDARY outcome

Timeframe: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

Outcome measures

Measure	Change From Baseline Single Dose of Oxymorphone IR: 5mg Tablet n=9 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 10mg Tablet n=3 Participants Change from Baseline	Change From Baseline Single Dose Oxymorphone IR: 15mg Tablet n=8 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 5mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 10mg Tablet n=5 Participants Change from Baseline	Change From Baseline Multiple Dose Oxymorphone IR: 15mg Tablet n=9 Participants Change from Baseline
Terminal Half-life of Single Dose of Oxymorphone by Treatment Group	12.099 hour Standard Deviation 9.9336	15.900 hour Standard Deviation 18.2533	19.974 hour Standard Deviation 22.4488	19.215 hour Standard Deviation 37.3737	23.635 hour Standard Deviation 33.6381	22.520 hour Standard Deviation 15.3063

Adverse Events

Single Dose of Oxymorphone IR: 5mg Tablet

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Single Dose of Oxymorphone IR: 10mg Tablet

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Single Dose of Oxymorphone IR: 15mg Tablet

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Multiple Dose of Oxymorphone IR: 5mg Tablet

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Multiple Dose of Oxymorphone IR: 10mg Tablet

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Multiple Dose of Oxymorphone IR: 15mg Tablet

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Dose of Oxymorphone IR: 5mg Tablet n=13 participants at risk	Single Dose of Oxymorphone IR: 10mg Tablet n=9 participants at risk	Single Dose of Oxymorphone IR: 15mg Tablet n=11 participants at risk	Multiple Dose of Oxymorphone IR: 5mg Tablet n=9 participants at risk	Multiple Dose of Oxymorphone IR: 10mg Tablet n=8 participants at risk	Multiple Dose of Oxymorphone IR: 15mg Tablet n=8 participants at risk
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Injury, poisoning and procedural complications Fat embolism	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Injury, poisoning and procedural complications Failure of implant	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	9.1% 1/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Eye disorders Pupils unequal	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Eye disorders Vision blurred	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Headache	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Investigations Somatosensory evoked	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Monoplegia	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Spinal cord oedema	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.

Other adverse events

Measure	Single Dose of Oxymorphone IR: 5mg Tablet n=13 participants at risk	Single Dose of Oxymorphone IR: 10mg Tablet n=9 participants at risk	Single Dose of Oxymorphone IR: 15mg Tablet n=11 participants at risk	Multiple Dose of Oxymorphone IR: 5mg Tablet n=9 participants at risk	Multiple Dose of Oxymorphone IR: 10mg Tablet n=8 participants at risk	Multiple Dose of Oxymorphone IR: 15mg Tablet n=8 participants at risk
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	37.5% 3/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Cardiac disorders Tachycardia	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Gastrointestinal disorders Constipation	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	9.1% 1/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	33.3% 3/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	50.0% 4/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Gastrointestinal disorders Nausea	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	22.2% 2/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	9.1% 1/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	44.4% 4/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	25.0% 2/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Gastrointestinal disorders Vomiting	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	22.2% 2/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
General disorders Pyrexia	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	36.4% 4/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	25.0% 2/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Investigations Oxygen saturation decreased	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	22.2% 2/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	25.0% 2/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	25.0% 2/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Dizziness	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	25.0% 2/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Headache	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	33.3% 3/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Hypoaesthesia	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Nervous system disorders Sedation	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Psychiatric disorders Anxiety	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Renal and urinary disorders Urinary retention	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	9.1% 1/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	37.5% 3/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	0.00% 0/11 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	11.1% 1/9 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.	12.5% 1/8 • All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.

Additional Information

Saji Vijayan

Endo Pharmaceuticals

Phone: (800) 462-3636

Email: ClinicalTrials@Endo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place