Trial Outcomes & Findings for Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation (NCT NCT04310579)
NCT ID: NCT04310579
Last Updated: 2024-05-21
Results Overview
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of midazolam combined with oxycodone vs. oxycodone alone was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
Part 1: 2 hour timepoint on treatment period Day 1
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Part 1 Treatment Sequence CADB
Participants first received treatment C and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment D: Oral placebo + placebo IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 1 Treatment Sequence DCBA
Participants first received treatment D and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment D: Oral placebo + placebo IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Lead-In
Read Rebreathing Reproducibility Assessment
|
Part 1 Treatment Sequence ABCD
Participants first received treatment A and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment D: Oral placebo + placebo IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 1 Treatment Sequence BDAC
Participants first received treatment B and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment D: Oral placebo + placebo IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 2 Treatment Sequence ABC
Participants first received treatment A and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
|
Part 2 Treatment Sequence ACB
Participants first received treatment A and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
|
Part 2 Treatment Sequence BAC
Participants first received treatment B and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
|
Part 2 Treatment Sequence BCA
Participants first received treatment B and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
|
Part 2 Treatment Sequence CAB
Participants first received treatment C and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
|
Part 2 Treatment Sequence CBA
Participants first received treatment C and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
10
|
5
|
5
|
4
|
5
|
3
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
10
|
5
|
5
|
3
|
3
|
3
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1 Treatment Sequence CADB
Participants first received treatment C and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment D: Oral placebo + placebo IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 1 Treatment Sequence DCBA
Participants first received treatment D and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment D: Oral placebo + placebo IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Lead-In
Read Rebreathing Reproducibility Assessment
|
Part 1 Treatment Sequence ABCD
Participants first received treatment A and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV Treatment D: Oral placebo + placebo IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 1 Treatment Sequence BDAC
Participants first received treatment B and then crossed over to the sequential treatments with two days of washout in between treatments. Treatments are as follows:
Treatment B: Oral placebo + 0.0375-0.075 mg/kg midazolam IV Treatment D: Oral placebo + placebo IV Treatment A: 10-15mg Immediate Release (IR) Oxycodone tablet + placebo IV Treatment C: 10-15 mg IR Oxycodone tablet + 0.0375-0.075 mg/kg midazolam IV
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 2 Treatment Sequence ABC
Participants first received treatment A and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
|
Part 2 Treatment Sequence ACB
Participants first received treatment A and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
|
Part 2 Treatment Sequence BAC
Participants first received treatment B and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
|
Part 2 Treatment Sequence BCA
Participants first received treatment B and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
|
Part 2 Treatment Sequence CAB
Participants first received treatment C and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
|
Part 2 Treatment Sequence CBA
Participants first received treatment C and then crossed over to the sequential treatments with seven days of washout in between treatments. Treatments are as follows:
Treatment C: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
Treatment B: Subjects receive oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
Treatment A: Subjects receive oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive COVID-19 test
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation
Baseline characteristics by cohort
| Measure |
Lead-In
n=10 Participants
Read Rebreathing Reproducibility Assessment
|
Part 1 Oxycodone and Midazolam
n=20 Participants
In one arm subjects receive oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo 1x per day.
In a second arm (randomized cross-over), subjects receive midazolam 0.0375-0.075 mg/kg IV and oral placebo tablet 1x per day.
In a third arm (randomized cross-over), subjects receive oxycodone 10-15 mg IR tablet and 0.0375-0.075 mg/kg midazolam IV 1x per day.
In a fourth arm (randomized cross-over), subjects receive oral placebo tablet and placebo IV 1x per day.
Note: Initial doses of oxycodone will be 10 mg, but may be increased to 15 mg if necessary based on criteria specified in protocol. Initial doses of midazolam will be 0.0375 mg/kg but may be increased to 0.075 mg/kg based on criteria specified in protocol.
|
Part 2 Oxycodone, Paroxetine, and Quetiapine
n=25 Participants
In one arm, subjects receive: oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
In a second arm (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
In a third arm (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
36 years
n=7 Participants
|
35 years
n=5 Participants
|
35 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
20 participants
n=7 Participants
|
25 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Body weight
|
77 kg
n=5 Participants
|
80 kg
n=7 Participants
|
68 kg
n=5 Participants
|
75 kg
n=4 Participants
|
|
Body mass index
|
25.6 kg/m^2
n=5 Participants
|
27.4 kg/m^2
n=7 Participants
|
24.8 kg/m^2
n=5 Participants
|
25.3 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: Part 1: 2 hour timepoint on treatment period Day 1Population: All participants who finished more than 1 study period and completed rebreathing assessments at the 2-hour time point on day 1 were included in the primary analysis without imputation of missing data. One participant completed the study but did not have any completed rebreathing assessments at the 2-hour time point. Midazolam dose was escalated after the first five subjects, so those subjects who received the lower dose are excluded from summaries and comparison as specified in the protocol
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of midazolam combined with oxycodone vs. oxycodone alone was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=14 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 1 - Minute Ventilation at the 55 mm Hg End Tidal Carbon Dioxide (CO2) Point (VE55) on Day 1 for Oxycodone Combined With Midazolam and Oxycodone Alone.
|
21.9 L/min
Interval 17.1 to 26.6
|
24.1 L/min
Interval 20.1 to 28.1
|
—
|
PRIMARY outcome
Timeframe: Part 2: 5 hour timepoint on Day 1Population: All participants that completed paired rebreathing assessments with placebo-oxycodone and at least one of the other two study treatments (paroxetine-oxycodone or quetiapine-oxycodone combinations) for day 1 were included in the primary analysis.
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 1 was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=20 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=20 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=20 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - Minute Ventilation at the 55 mm Hg End Tidal Carbon Dioxide (CO2) Point (VE55) on Day 1 for Paroxetine or Quetiapine Combined With Oxycodone and Oxycodone Alone.
|
34.1 L/min
Interval 31.1 to 37.2
|
29.2 L/min
Interval 25.7 to 32.7
|
33.0 L/min
Interval 30.0 to 36.0
|
PRIMARY outcome
Timeframe: Part 2: 5 hour timepoint on Day 5Population: All participants that completed paired rebreathing assessments with placebo-oxycodone and at least one of the other two study treatments (paroxetine-oxycodone or quetiapine-oxycodone combinations) for day 5 were included in the primary analysis.
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 5 was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=19 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - Minute Ventilation at the 55 mm Hg End Tidal Carbon Dioxide (CO2) Point (VE55) on Day 5 for Paroxetine or Quetiapine Combined With Oxycodone and Oxycodone Alone.
|
35.3 L/min
Interval 31.4 to 39.2
|
25.1 L/min
Interval 21.2 to 29.0
|
34.7 L/min
Interval 30.9 to 38.5
|
SECONDARY outcome
Timeframe: Part 1: 2 hour timepoint on Day 1Population: All participants who finished more than 1 study period and completed rebreathing assessments at the 2-hour time point on day 1 were included in the primary analysis without imputation of missing data. One participant completed the study but did not have any completed rebreathing assessments at the 2-hour time point. Midazolam dose was escalated after the first five subjects, so those subjects who received the lower dose are excluded from summaries and comparison as specified in the protocol
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of oxycodone or midazolam alone compared to placebo was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=19 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=14 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 1 - Minute Ventilation at the 55 mm Hg End Tidal Carbon Dioxide (CO2) Point (VE55) for Oxycodone, Midazolam, and Placebo.
|
30.9 L/min
Interval 26.9 to 34.8
|
30.0 L/min
Interval 25.4 to 34.5
|
24.1 L/min
Interval 20.1 to 28.1
|
SECONDARY outcome
Timeframe: Part 2: 5 hour timepoint on Day 4Population: All participants that completed paired rebreathing assessments with placebo-oxycodone and at least one of the other two study treatments (paroxetine-oxycodone or quetiapine-oxycodone combinations) for day 4 were included in the primary analysis.
VE55 was estimated by analyzing rebreathing data using linear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2). Rebreathing data were reviewed by 2 independent assessors blinded to study treatment and time of assessments to evaluate completeness of data for study outcomes. Resulting VE55 data of paroxetine, quetiapine, and placebo on Day 4 was compared using a linear mixed effects model with baseline VE55 as a continuous variable; treatment, sequence, and period as categorical variables; and participant as a random effect. R software was used for all analyses.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=19 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - Minute Ventilation at the 55 mm Hg End Tidal Carbon Dioxide (CO2) Point (VE55) on Day 4 for Paroxetine, Quetiapine, and Placebo
|
41.7 L/min
Interval 37.7 to 45.6
|
32.4 L/min
Interval 28.2 to 36.5
|
42.8 L/min
Interval 38.7 to 46.8
|
SECONDARY outcome
Timeframe: Part 1: Day 1 at 0, 1, 2, 3, 4, 6, 8, 12, 24 hourPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter after dosing
Cmax will be the maximum observed concentration for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=20 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=20 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 1 - Maximum Observed Plasma Concentration (Cmax) of Oxycodone Alone vs. in Combination With Midazolam
|
19.8 ng/mL
Geometric Coefficient of Variation 27
|
21.8 ng/mL
Geometric Coefficient of Variation 37
|
—
|
SECONDARY outcome
Timeframe: Part 2: Day 1 at 3, 4, 5, 6, 9, 12, 24 hourPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter on day 1 after dosing
Cmax will be the maximum observed concentration for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=20 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=20 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - Cmax of Oxycodone Alone vs. in Combination With Paroxetine or Quetiapine on Day 1
|
18.3 ng/mL
Geometric Coefficient of Variation 30
|
19.1 ng/mL
Geometric Coefficient of Variation 25
|
22.9 ng/mL
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Part 2: Day 5 at 3, 4, 5, 6, 9, 12, 24 hourPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter on day 1 after dosing
Cmax will be the maximum observed concentration for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=19 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - Cmax of Oxycodone Alone vs. in Combination With Paroxetine or Quetiapine on Day 5
|
18.0 ng/mL
Geometric Coefficient of Variation 26
|
23.4 ng/mL
Geometric Coefficient of Variation 26
|
24.9 ng/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Part 1: Day 1 at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hourPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter after dosing
AUC will be calculated using noncompartmental methods for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=20 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=20 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 1 - Area Under the Plasma Concentration-time Curve (AUC) of Oxycodone Alone vs. in Combination With Midazolam
|
129 ng/mL*hour
Geometric Coefficient of Variation 34
|
136 ng/mL*hour
Geometric Coefficient of Variation 38
|
—
|
SECONDARY outcome
Timeframe: Part 2: Day 1 at 0 (pre-dose), 3, 4, 5, 6, 8, 9, 12, 24 hoursPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter on day 1 after dosing
AUC will be calculated using noncompartmental methods for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=20 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - AUC of Oxycodone Alone vs. in Combination With Paroxetine or Quetiapine on Day 1
|
107 ng/mL*hr
Geometric Coefficient of Variation 25
|
107 ng/mL*hr
Geometric Coefficient of Variation 29
|
113 ng/mL*hr
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: Part 2: Day 5 on 0 (pre-dose), 3, 4, 5, 6, 8, 9, 12, 24 hoursPopulation: The pharmacokinetic population will include all subjects who receive study drug and have at least 1 estimable PK parameter on day 5 after dosing
AUC will be calculated using noncompartmental methods for each treatment. Observations will be summarized using descriptive statistics.
Outcome measures
| Measure |
Part 1: Oxycodone and Midazolam
n=19 Participants
Oxycodone 10 mg IR tablet and 0.075 mg/kg midazolam IV
|
Part 1: Oxycodone
n=19 Participants
Oxycodone 10-15 mg immediate release (IR) tablets and intravenous (IV) placebo
|
Part 2: Oxycodone + Quetiapine
n=19 Participants
Oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5
|
|---|---|---|---|
|
Part 2 - AUC of Oxycodone Alone vs. in Combination With Paroxetine or Quetiapine on Day 5
|
102 ng/mL*hr
Geometric Coefficient of Variation 24
|
112 ng/mL*hr
Geometric Coefficient of Variation 30
|
129 ng/mL*hr
Geometric Coefficient of Variation 23
|
Adverse Events
Lead-In
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Midazolam
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1: Oxycodone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1: Oxycodone + Midazolam
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Oxycodone + Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 2: Oxycodone + Paroxetine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2: Oxycodone + Quetiapine
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lead-In
n=10 participants at risk
Read Rebreathing Reproducibility Assessment (No intervention)
|
Part 1: Placebo
n=20 participants at risk
Oral placebo + placebo IV (Part 1)
|
Part 1: Midazolam
n=20 participants at risk
Oral placebo + midazolam IV (Part 1)
|
Part 1: Oxycodone
n=20 participants at risk
Oxycodone + placebo IV (Part 1)
|
Part 1: Oxycodone + Midazolam
n=20 participants at risk
Oxycodone + midazolam IV (Part 1)
|
Part 2: Oxycodone + Placebo
n=25 participants at risk
Oxycodone + Placebo (Part 2)
|
Part 2: Oxycodone + Paroxetine
n=25 participants at risk
Oxycodone + Paroxetine (Part 2)
|
Part 2: Oxycodone + Quetiapine
n=25 participants at risk
Oxycodone + Quetiapine (Part 2)
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pallor
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Eye disorders
Conjunctival hyparaemia
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 7 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
15.0%
3/20 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
32.0%
8/25 • Number of events 13 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
48.0%
12/25 • Number of events 16 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 6 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 4 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Fatigue
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
24.0%
6/25 • Number of events 7 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Medical device site erythema
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Medical device site irritation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 4 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Vessel puncture site pruritus
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
General disorders
Vessel puncture site irritation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
16.0%
4/25 • Number of events 6 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
24.0%
6/25 • Number of events 7 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
28.0%
7/25 • Number of events 8 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 5 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
15.0%
3/20 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
28.0%
7/25 • Number of events 9 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
28.0%
7/25 • Number of events 7 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
20.0%
5/25 • Number of events 5 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
12.0%
3/25 • Number of events 6 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
28.0%
7/25 • Number of events 11 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Nervous system disorders
Vertigo
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 3 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
10.0%
2/20 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
8.0%
2/25 • Number of events 2 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
5.0%
1/20 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/20 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
0.00%
0/25 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
4.0%
1/25 • Number of events 1 • Lead-in: 4 Days, Part 1: 11 Days, Part 2: 30 Days
|
Additional Information
David Strauss, MD, PhD
U.S. Food and Drug Administration
Phone: 301-796-6323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place