Trial Outcomes & Findings for Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience (NCT NCT04570436)

NCT ID: NCT04570436

Last Updated: 2024-07-24

Results Overview

Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: up to 72 hours after treatments
• Results posted on: 2024-07-24

Participant Flow

Subjects entered a Qualification phase involving a naloxone challenge test (to exclude subjects who were opioid dependent) and a drug discrimination test (to confirm they can tell the difference between diazepam and placebo). Only subjects who passed the tests in the Qualification phase were randomized into the Treatment phase where they received the 5 different single dose study treatments, each separated by a washout of at least 14 days, in the order specified for Sequences 1-10 below

Participant milestones

Measure	Sequence 1 Period 1 Gabapentin 600 mg - Period 2 Gabapentin 1200 mg - Period 3 Placebo - Period 4 Gabapentin 1800 mg - Period 5 Diazepam 20 mg	Sequence 2 Period 1 Gabapentin 600 mg - Period 2 Placebo - Period 3 Gabapentin 1200 mg - Period 4 Diazepam 20 mg - Period 5 Gabapentin 1800 mg	Sequence 3 Period 1 Gabapentin 1200 mg - Period 2 Gabapentin 600 mg - Period 3 Gabapentin 1800 mg - Period 4 Placebo - Period 5 Diazepam 20 mg	Sequence 4 Period 1 Gabapentin 1200 mg - Period 2 Gabapentin 1800 mg - Period 3 Gabapentin 600 mg - Period 4 Diazepam 20 mg - Period 5 Placebo	Sequence 5 Period 1 Gabapentin 1800 mg - Period 2 Gabapentin 1200 mg - Period 3 Diazepam 20 mg - Period 4 Gabapentin 600 mg - Period 5 Placebo	Sequence 6 Period 1 Gabapentin 1800 mg - Period 2 Diazepam 20 mg - Period 3 Gabapentin 1200 mg - Period 4 Placebo - Period 5 Gabapentin 600 mg	Sequence 7 Period 1 Diazepam 20 mg - Period 2 Gabapentin 1800 mg - Period 3 Placebo - Period 4 Gabapentin 1200 mg - Period 5 Gabapentin 600 mg	Sequence 8 Period 1 Diazepam 20 mg - Period 2 Placebo - Period 3 Gabapentin 1800 mg - Period 4 Gabapentin 600 mg - Period 5 Gabapentin 1200 mg	Sequence 9 Period 1 Placebo - Period 2 Gabapentin 600 mg - Period 3 Diazepam 20 mg - Period 4 Gabapentin 1200 mg -Period 5 Gabapentin 1800 mg	Sequence 10 Period 1 Placebo - Period 2 Diazepam 20 mg - Period 3 Gabapentin 600 mg - Period 4 Gabapentin 1800 mg - Period 5 Gabapentin 1200 mg
Overall Study STARTED	5	5	6	5	5	5	6	5	5	5
Overall Study COMPLETED	4	5	5	5	5	5	6	5	5	5
Overall Study NOT COMPLETED	1	0	1	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Sequence 1 Period 1 Gabapentin 600 mg - Period 2 Gabapentin 1200 mg - Period 3 Placebo - Period 4 Gabapentin 1800 mg - Period 5 Diazepam 20 mg	Sequence 2 Period 1 Gabapentin 600 mg - Period 2 Placebo - Period 3 Gabapentin 1200 mg - Period 4 Diazepam 20 mg - Period 5 Gabapentin 1800 mg	Sequence 3 Period 1 Gabapentin 1200 mg - Period 2 Gabapentin 600 mg - Period 3 Gabapentin 1800 mg - Period 4 Placebo - Period 5 Diazepam 20 mg	Sequence 4 Period 1 Gabapentin 1200 mg - Period 2 Gabapentin 1800 mg - Period 3 Gabapentin 600 mg - Period 4 Diazepam 20 mg - Period 5 Placebo	Sequence 5 Period 1 Gabapentin 1800 mg - Period 2 Gabapentin 1200 mg - Period 3 Diazepam 20 mg - Period 4 Gabapentin 600 mg - Period 5 Placebo	Sequence 6 Period 1 Gabapentin 1800 mg - Period 2 Diazepam 20 mg - Period 3 Gabapentin 1200 mg - Period 4 Placebo - Period 5 Gabapentin 600 mg	Sequence 7 Period 1 Diazepam 20 mg - Period 2 Gabapentin 1800 mg - Period 3 Placebo - Period 4 Gabapentin 1200 mg - Period 5 Gabapentin 600 mg	Sequence 8 Period 1 Diazepam 20 mg - Period 2 Placebo - Period 3 Gabapentin 1800 mg - Period 4 Gabapentin 600 mg - Period 5 Gabapentin 1200 mg	Sequence 9 Period 1 Placebo - Period 2 Gabapentin 600 mg - Period 3 Diazepam 20 mg - Period 4 Gabapentin 1200 mg -Period 5 Gabapentin 1800 mg	Sequence 10 Period 1 Placebo - Period 2 Diazepam 20 mg - Period 3 Gabapentin 600 mg - Period 4 Gabapentin 1800 mg - Period 5 Gabapentin 1200 mg
Overall Study Adverse Event	0	0	1	0	0	0	0	0	0	0
Overall Study Physician Decision	1	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

Baseline characteristics by cohort

Measure	Modified Completer Population n=41 Participants All participants who completed all 5 treatment periods of the Treatment Phase but excluding those subjects who had scores for the primary endpoint (maximum Drug Liking Visual Analog Scale score) that were within 5 points across all 5 treatments and/or had high placebo scores for the primary endpoint (maximum Drug Liking Visual Analog Scale score for placebo was \> 60 on a 100 point scale and the primary endpoint for placebo was 5 or more points greater than that for the positive control, diazepam). This was the primary analysis population.
Age, Continuous	34.2 Years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 hours after treatments

Population: Modified completer population

Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).	51.98 Score on a scale Standard Error 0.955	79.37 Score on a scale Standard Error 2.533	61.95 Score on a scale Standard Error 2.418	61.39 Score on a scale Standard Error 2.209	60.95 Score on a scale Standard Error 2.270

SECONDARY outcome

Timeframe: up to 72 hours after treatments

Population: Modified completer population

Time after dosing when the maximum effect for Drug Liking VAS is reached

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])	0.2 Hours Interval 0.2 to 72.0	1.51 Hours Interval 0.2 to 8.0	2.0 Hours Interval 0.2 to 48.0	2.0 Hours Interval 0.2 to 12.0	2.5 Hours Interval 0.2 to 12.0

SECONDARY outcome

Timeframe: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Population: Modified completer population

Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking". The minimum and maximum possible scores are approximately 0 and 7200 if a subject scores 0 mm (strong disliking) and 100 mm (strong liking) respectively at every timepoint up to 72 hours.

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])	3441.77 units on a scale * hour Standard Error 101.695	3778.02 units on a scale * hour Standard Error 124.372	3588.67 units on a scale * hour Standard Error 107.642	3601.72 units on a scale * hour Standard Error 46.538	3652.27 units on a scale * hour Standard Error 114.555

SECONDARY outcome

Timeframe: up to 72 hours after treatments

Population: Modified completer population

Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 ="extremely"

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Unipolar VAS for "High" (Maximum Effect, Emax)	5.80 Score on a scale Standard Error 2.272	61.56 Score on a scale Standard Error 5.056	23.02 Score on a scale Standard Error 4.351	26.93 Score on a scale Standard Error 4.717	27.66 Score on a scale Standard Error 4.753

SECONDARY outcome

Timeframe: up to 72 hours after treatments

Population: Modified completer population

Time after dosing when the maximum effect for "High" VAS is reached

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Unipolar VAS for "High" (Time for Maximum Effect, Emax [TEmax])	0.20 Hours Interval 0.2 to 6.0	1.96 Hours Interval 0.2 to 6.0	1.50 Hours Interval 0.2 to 8.0	2.00 Hours Interval 0.2 to 8.0	2.50 Hours Interval 0.2 to 24.0

SECONDARY outcome

Timeframe: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Population: Modified completer population

Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0 ="not at all" and 100 ="extremely". The minimum and maximum possible scores are 0 and approximately 7200 if a subject scores 0 mm (not at all) and 100 mm (extremely) respectively at every timepoint up to 72 hours.

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])	15.06 units on a scale * hour Standard Error 5.993	250.38 units on a scale * hour Standard Error 40.596	83.08 units on a scale * hour Standard Error 23.583	112.74 units on a scale * hour Standard Error 39.041	109.07 units on a scale * hour Standard Error 24.600

SECONDARY outcome

Timeframe: At 24 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Take Drug Again" at 24 Hour Post Dose	48.66 Score on a scale Standard Error 1.955	63.10 Score on a scale Standard Error 3.218	58.28 Score on a scale Standard Error 2.453	55.63 Score on a scale Standard Error 2.318	54.90 Score on a scale Standard Error 2.773

SECONDARY outcome

Timeframe: At 36 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Take Drug Again" at 36 Hour Post Dose	49.27 Score on a scale Standard Error 1.392	64.95 Score on a scale Standard Error 2.846	55.33 Score on a scale Standard Error 2.546	55.73 Score on a scale Standard Error 1.988	54.93 Score on a scale Standard Error 2.403

SECONDARY outcome

Timeframe: At 48 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Take Drug Again" at 48 Hour Post Dose	49.24 Score on a scale Standard Error 1.390	62.24 Score on a scale Standard Error 3.232	55.90 Score on a scale Standard Error 1.954	52.80 Score on a scale Standard Error 1.785	53.59 Score on a scale Standard Error 2.150

SECONDARY outcome

Timeframe: At 72 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Take Drug Again" at 72 Hour Post Dose	49.17 Score on a scale Standard Error 1.402	63.88 Score on a scale Standard Error 3.679	55.90 Score on a scale Standard Error 1.921	53.76 Score on a scale Standard Error 2.583	54.46 Score on a scale Standard Error 2.184

SECONDARY outcome

Timeframe: At 24 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Overall Drug Liking" at 24 Hour Post Dose	48.20 Score on a scale Standard Error 1.909	63.66 Score on a scale Standard Error 3.578	57.10 Score on a scale Standard Error 2.560	54.15 Score on a scale Standard Error 2.618	53.90 Score on a scale Standard Error 2.602

SECONDARY outcome

Timeframe: At 36 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Overall Drug Liking" at 36 Hour Post Dose	49.59 Score on a scale Standard Error 1.584	61.83 Score on a scale Standard Error 2.962	54.75 Score on a scale Standard Error 2.952	55.63 Score on a scale Standard Error 1.757	53.49 Score on a scale Standard Error 2.109

SECONDARY outcome

Timeframe: At 48 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Overall Drug Liking" at 48 Hour Post Dose	49.68 Score on a scale Standard Error 1.467	61.07 Score on a scale Standard Error 2.992	54.83 Score on a scale Standard Error 2.485	54.66 Score on a scale Standard Error 2.156	53.37 Score on a scale Standard Error 2.107

SECONDARY outcome

Timeframe: At 72 hours after treatment

Population: Modified completer population

100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".

Outcome measures

Measure	Placebo n=41 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=41 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=41 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=41 Participants single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=41 Participants single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Bipolar VAS for "Overall Drug Liking" at 72 Hour Post Dose	49.56 Score on a scale Standard Error 1.503	61.46 Score on a scale Standard Error 3.449	55.68 Score on a scale Standard Error 2.117	55.10 Score on a scale Standard Error 2.222	53.46 Score on a scale Standard Error 2.606

SECONDARY outcome

Timeframe: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Population: Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest.

Maximum plasma concentration (Cmax) of gabapentin

Outcome measures

Measure	Placebo n=52 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=52 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=51 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Cmax of Gabapentin	4223.47 nanograms/milliliter Standard Deviation 1048.963	6106.90 nanograms/milliliter Standard Deviation 1355.048	7373.15 nanograms/milliliter Standard Deviation 1874.185	—	—

SECONDARY outcome

Timeframe: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

Population: Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Time when the maximum concentration of gabapentin is reached

Outcome measures

Measure	Placebo n=52 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=52 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=51 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Tmax of Gabapentin	2.78 Hours Interval 1.0 to 6.1	2.55 Hours Interval 1.0 to 6.1	2.55 Hours Interval 1.0 to 6.1	—	—

SECONDARY outcome

Timeframe: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

Population: Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Area under the effect time profile from time 0 to the time of the last quantifiable concentration (AUClast) of gabapentin

Outcome measures

Measure	Placebo n=52 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=52 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=51 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
AUClast of Gabapentin	41848.88 nanograms*hour/milliliter Standard Deviation 10659.677	66972.60 nanograms*hour/milliliter Standard Deviation 15921.032	80483.05 nanograms*hour/milliliter Standard Deviation 22369.826	—	—

SECONDARY outcome

Timeframe: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

Population: Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Terminal half-life (t½) of gabapentin

Outcome measures

Measure	Placebo n=51 Participants single dose placebo: participants received a single oral dose of placebo	Diazepam 20 mg n=52 Participants single dose diazepam 20 mg: participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=50 Participants single dose gabapentin 600 mg: participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg single dose gabapentin 1200 mg: participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg single dose gabapentin 1800 mg: participants received a single oral dose of gabapentin 1800 mg
Terminal Half-life of Gabapentin	7.69 Hours Standard Deviation 2.496	13.83 Hours Standard Deviation 12.988	14.43 Hours Standard Deviation 11.130	—	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Diazepam 20 mg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Gabapentin 600 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Gabapentin 1200 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Gabapentin 1800 mg

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=50 participants at risk Participants received a single oral dose of placebo	Diazepam 20 mg n=50 participants at risk Participants received a single oral dose of 20 mg dose of diazepam	Gabapentin 600 mg n=52 participants at risk Participants received a single oral dose of gabapentin 600 mg	Gabapentin 1200 mg n=52 participants at risk Participants received a single oral dose of gabapentin 1200 mg	Gabapentin 1800 mg n=51 participants at risk Participants received a single oral dose of gabapentin 1800 mg
Gastrointestinal disorders Nausea	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	1.9% 1/52 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.8% 2/52 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/51 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Somnolence	4.0% 2/50 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	30.0% 15/50 • Number of events 15 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	13.5% 7/52 • Number of events 7 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	15.4% 8/52 • Number of events 8 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	19.6% 10/51 • Number of events 10 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Lethargy	4.0% 2/50 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	12.0% 6/50 • Number of events 6 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	7.7% 4/52 • Number of events 4 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.8% 2/52 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.9% 2/51 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Dizziness	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	4.0% 2/50 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	1.9% 1/52 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	9.6% 5/52 • Number of events 5 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	9.8% 5/51 • Number of events 5 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Headache	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	7.7% 4/52 • Number of events 4 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	5.9% 3/51 • Number of events 3 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Depressed level of consciousness	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	5.9% 3/51 • Number of events 3 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
General disorders Fatigue	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	10.0% 5/50 • Number of events 5 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	5.8% 3/52 • Number of events 3 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	7.7% 4/52 • Number of events 4 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.9% 2/51 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
General disorders Feeling of relaxation	4.0% 2/50 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	8.0% 4/50 • Number of events 4 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	5.8% 3/52 • Number of events 3 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.9% 2/51 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Psychiatric disorders Euphoric mood	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	12.0% 6/50 • Number of events 6 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	11.5% 6/52 • Number of events 6 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	9.6% 5/52 • Number of events 5 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	7.8% 4/51 • Number of events 4 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Sedation	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	3.8% 2/52 • Number of events 2 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Nervous system disorders Cognitive idsorder	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Psychiatric disorders Anxiety	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/51 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Gastrointestinal disorders Abdominal discomfort	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Gastrointestinal disorders Abdominal distension	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Eye disorders Scleral disorder	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/51 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Eye disorders Visual impairment	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/51 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Eye disorders Diplopia	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Infections and infestations COVID-19	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	1.9% 1/52 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Skin and subcutaneous tissue disorders Hyperhidrosis	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Investigations SARS-CoV-2 test positive	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit
Cardiac disorders Tachycardia	2.0% 1/50 • Number of events 1 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/50 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/52 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit	0.00% 0/51 • During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed treatment periods, and it lasted up to approximately 13 weeks. Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dosing counted under the previous treatment visit

Additional Information

Dik WH Ng

Viatris

Phone: +44 (0)1304 626895

Email: dik.ng@viatris.com

Results disclosure agreements

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