Trial Outcomes & Findings for Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users (NCT NCT05053126)
NCT ID: NCT05053126
Last Updated: 2023-08-14
Results Overview
Drug liking 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"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
up to 48 hours after treatment
Results posted on
2023-08-14
Participant Flow
Subjects were entered into 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 oxycodone and placebo). Only subjects who passed the tests in the Qualification phase were randomized into the Treatment phase where they received the 6 different single dose study treatments, each separated by a washout of at least 4 days, in the order specified for Sequences 1-6 below
Participant milestones
| Measure |
Sequence 1
Period 1: Placebo; Period 2: Oxycodone HCl 20 mg; Period 3: Pregabalin 450 mg plus Oxycodone HCl 20 mg; Period 4: Pregabalin 300 mg; Period 5: Pregabalin 300 mg plus Oxycodone HCl 20 mg; Period 6: Pregabalin 450 mg
|
Sequence 2
Period 1: Oxycodone HCl 20 mg; Period 2: Pregabalin 300 mg; Period 3: Placebo; Period 4: Pregabalin 450 mg; Period 5: Pregabalin 450 mg plus Oxycodone HCl 20 mg; Period 6: Pregabalin 300 mg plus Oxycodone HCl 20 mg
|
Sequence 3
Period 1: Pregabalin 300 mg; Period 2: Pregabalin 450 mg; Period 3: Oxycodone HCl 20 mg; Period 4: Pregabalin 300 mg plus Oxycodone HCl 20 mg; Period 5: Placebo; Period 6: Pregabalin 450 mg plus Oxycodone HCl 20 mg
|
Sequence 4
Period 1: Pregabalin 450 mg; Period 2: Pregabalin 300 mg plus Oxycodone HCl 20 mg; Period 3: Pregabalin 300 mg; Period 4: Pregabalin 450 mg plus Oxycodone HCl 20 mg; Period 5: Oxycodone HCl 20 mg; Period 6: Placebo
|
Sequence 5
Period 1: Pregabalin 300 mg plus Oxycodone HCl 20 mg; Period 2: Pregabalin 450 mg plus Oxycodone HCl 20 mg; Period 3: Pregabalin 450 mg; Period 4: Placebo; Period 5: Pregabalin 300 mg; Period 6: Oxycodone HCl 20 mg
|
Sequence 6
Period 1: Pregabalin 450 mg plus Oxycodone HCl 20 mg; Period 2: Placebo; Period 3: Pregabalin 300 mg plus Oxycodone HCl 20 mg; Period 4: Oxycodone HCl 20 mg; Period 5: Pregabalin 450 mg; Period 6: Pregabalin 300 mg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users
Baseline characteristics by cohort
| Measure |
Randomized Population
n=60 Participants
All participants who were randomized to a treatment sequence in the Treatment Phase.
|
|---|---|
|
Age, Continuous
|
32.8 Years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 48 hours after treatmentPopulation: Modified completer population
Drug liking 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"
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).
|
54.30 Score on a 100 mm scale
Standard Error 1.786
|
90.85 Score on a 100 mm scale
Standard Error 2.493
|
72.53 Score on a 100 mm scale
Standard Error 3.224
|
76.05 Score on a 100 mm scale
Standard Error 3.151
|
96.11 Score on a 100 mm scale
Standard Error 1.559
|
95.06 Score on a 100 mm scale
Standard Error 1.885
|
SECONDARY outcome
Timeframe: up to 48 hours after treatmentPopulation: 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=53 Participants
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Unipolar VAS for "High" - Maximum Effect (Emax)
|
10.83 Score on a 100 mm scale
Standard Error 4.020
|
85.83 Score on a 100 mm scale
Standard Error 4.333
|
55.83 Score on a 100 mm scale
Standard Error 6.180
|
60.43 Score on a 100 mm scale
Standard Error 5.801
|
91.36 Score on a 100 mm scale
Standard Error 3.237
|
92.23 Score on a 100 mm scale
Standard Error 3.264
|
SECONDARY outcome
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)Population: Modified completer population
100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment\*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Bipolar VAS for "Take Drug Again"
|
53.58 Score on a 100 mm scale
Standard Error 2.664
|
77.05 Score on a 100 mm scale
Standard Error 2.668
|
63.98 Score on a 100 mm scale
Standard Error 2.661
|
64.87 Score on a 100 mm scale
Standard Error 2.669
|
77.91 Score on a 100 mm scale
Standard Error 2.674
|
75.92 Score on a 100 mm scale
Standard Error 2.664
|
SECONDARY outcome
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)Population: Modified completer population
100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment\*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Bipolar VAS for "Overall Drug Liking"
|
53.74 Score on a 100 mm scale
Standard Error 2.762
|
75.73 Score on a 100 mm scale
Standard Error 2.766
|
60.14 Score on a 100 mm scale
Standard Error 2.760
|
63.54 Score on a 100 mm scale
Standard Error 2.767
|
74.86 Score on a 100 mm scale
Standard Error 2.772
|
75.01 Score on a 100 mm scale
Standard Error 2.762
|
SECONDARY outcome
Timeframe: up to 48 hours after treatmentPopulation: Modified completer population
100 mm visual analog scale for the question "At this moment, I can feel any drug effects" where 0 = "not at all" and 100 = "extremely"
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=53 Participants
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Unipolar VAS for "Any Drug Effect"
|
2.14 Score on a 100 mm scale
Standard Error 2.076
|
29.97 Score on a 100 mm scale
Standard Error 2.075
|
16.68 Score on a 100 mm scale
Standard Error 2.073
|
20.00 Score on a 100 mm scale
Standard Error 2.075
|
36.55 Score on a 100 mm scale
Standard Error 2.075
|
40.98 Score on a 100 mm scale
Standard Error 2.075
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Oxycodone 20 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Lyrica 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lyrica 450 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lyrica 300mg With Oxycodone 20 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lyrica 450 mg With Oxycodone 20 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=58 participants at risk
Participants received a single oral dose of placebo
|
Oxycodone 20 mg
n=58 participants at risk
Participants received a single oral dose of oxycodone 20 mg
|
Lyrica 300 mg
n=58 participants at risk
Participants received a single oral dose of pregabalin 300 mg
|
Lyrica 450 mg
n=59 participants at risk
Participants received a single oral dose of pregabalin 450 mg
|
Lyrica 300mg With Oxycodone 20 mg
n=59 participants at risk
Participants received a single oral dose of pregabalin 300 mg and oxycodone 20 mg
|
Lyrica 450 mg With Oxycodone 20 mg
n=59 participants at risk
Participants received a single oral dose of pregabalin 450 mg and oxycodone 20 mg
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
8.6%
5/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
3.4%
2/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
8.5%
5/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
5.1%
3/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
5.1%
3/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Infections and infestations
COVID-19
|
1.7%
1/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
5.2%
3/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
5.1%
3/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
5.2%
3/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
|
Vascular disorders
Hypotension
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/58 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
1.7%
1/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
0.00%
0/59 • 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 Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 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 dose will be counted under the previous treatment visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER