Trial Outcomes & Findings for Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia (NCT NCT01769274)
NCT ID: NCT01769274
Last Updated: 2019-11-19
Results Overview
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Every 15 minutes from 0 to 4 hours post-dose
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Part A
Participants were exposed to pain stimulus. Reproducibility and repeatability of induced pain attacks and spontaneous reporting of pain by participants was established. Part A was performed for 1-2 days and maximum up to 7 days. Maximum duration between Part A and Part B was of 4 weeks.
|
Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771
On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of PF-05089771 1600 milligram (mg) on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of placebo matched to PF-05089771, followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months.
|
Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo
On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of placebo matched to PF-05089771 on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of PF-05089771 1600 mg, followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months.
|
|---|---|---|---|
|
Part B:Treatment Session2-Period4
COMPLETED
|
0
|
2
|
3
|
|
Part B:Treatment Session2-Period4
NOT COMPLETED
|
0
|
0
|
0
|
|
Part A
STARTED
|
5
|
0
|
0
|
|
Part A
COMPLETED
|
5
|
0
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B:Treatment Session1-Period1
STARTED
|
0
|
2
|
3
|
|
Part B:Treatment Session1-Period1
COMPLETED
|
0
|
2
|
3
|
|
Part B:Treatment Session1-Period1
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
0
|
2
|
3
|
|
Washout Period
COMPLETED
|
0
|
2
|
3
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B:Treatment Session1-Period2
STARTED
|
0
|
2
|
3
|
|
Part B:Treatment Session1-Period2
COMPLETED
|
0
|
2
|
3
|
|
Part B:Treatment Session1-Period2
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B:Treatment Session2-Period3
STARTED
|
0
|
2
|
3
|
|
Part B:Treatment Session2-Period3
COMPLETED
|
0
|
2
|
3
|
|
Part B:Treatment Session2-Period3
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B:Treatment Session2-Period4
STARTED
|
0
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
Baseline characteristics by cohort
| Measure |
All Participants
n=5 Participants
All participants who were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 18.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 15 minutes from 0 to 4 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose
|
2.08 Units on a scale
Standard Deviation 2.20
|
2.73 Units on a scale
Standard Deviation 2.68
|
1.95 Units on a scale
Standard Deviation 2.29
|
2.04 Units on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP2 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose
|
0.70 Units on a scale
Standard Deviation 0.64
|
0.61 Units on a scale
Standard Deviation 0.46
|
0.55 Units on a scale
Standard Deviation 0.51
|
1.08 Units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP3 to 10 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose
|
1.19 Units on a scale
Standard Deviation 1.22
|
1.55 Units on a scale
Standard Deviation 1.15
|
0.82 Units on a scale
Standard Deviation 0.52
|
1.39 Units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP4 to 28 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose
|
0.99 Units on a scale
Standard Deviation 0.52
|
0.91 Units on a scale
Standard Deviation 0.53
|
0.36 Units on a scale
Standard Deviation 0.08
|
0.77 Units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: From 0 hour to 4 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Maximum pain score in 4 hours period post-dosing is reported.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose
|
7.6 Units on a scale
Standard Deviation 1.7
|
8.0 Units on a scale
Standard Deviation 1.4
|
8.2 Units on a scale
Standard Deviation 2.1
|
8.6 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From post EP2 to 8 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. Maximum pain score in period from post EP2 to 8 hours post-dose is reported.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose
|
3.5 Units on a scale
Standard Deviation 1.7
|
5.7 Units on a scale
Standard Deviation 3.1
|
5.5 Units on a scale
Standard Deviation 3.3
|
7.8 Units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From the end of EP3 to 10 hours post dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. Maximum pain score in period from post EP3 to 10 hours post-dose is reported.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose
|
2.3 Units on a scale
Standard Deviation 2.6
|
6.0 Units on a scale
Standard Deviation 3.6
|
5.3 Units on a scale
Standard Deviation 2.6
|
8.3 Units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. Maximum pain score in period from post EP4 to 28 hours post-dose is reported.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose
|
7.3 Units on a scale
Standard Deviation 1.2
|
7.3 Units on a scale
Standard Deviation 2.5
|
5.7 Units on a scale
Standard Deviation 2.1
|
8.0 Units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: From 0 hour to 4 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. The duration of time that participants experienced PI-NRS score greater than 5 from the 0 hours to 4 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose
|
20.0 Minutes
Standard Deviation 42.0
|
29.4 Minutes
Standard Deviation 63.0
|
10.4 Minutes
Standard Deviation 23.3
|
8.2 Minutes
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from in period from post EP2 to 8 hours post-dose is reported.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from the post EP3 to 10 hours post dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=4 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=4 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Duration When PI-NRS Scores Were >5 - From Post EP3 to 10 Hours Post-dose
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 10.4
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from post EP4 to 28 hours post-dose.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=3 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=3 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Duration When PI-NRS Scores Were >5 - From Post EP4 to 28 Hours Post-dose
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
0.0 Minutes
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At 4 hour post-dose or at time of first rescue therapy, whichever occurred firstPopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.
Participant was asked "How would you rate the study medication you received for pain?". The participant was provided the following choices as an answer: excellent=4; good=3; fair=2; poor=1. Response to this question, was participant's overall impression (global evaluation) of the study medication at 4 hour post-dose or at time of first rescue treatment or medication, which ever occurred first.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Participant's Global Satisfaction Score
Good Score
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant's Global Satisfaction Score
Excellent Score
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant's Global Satisfaction Score
Poor Score
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Participant's Global Satisfaction Score
Fair Score
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to maximum of 24 hours post-dosePopulation: Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Number of Participants Analyzed = number of participants evaluable for this outcome measure.
Time to rescue medication (hour) was calculated as: date/time of rescue medication minus date/time of first dose for each period. If participant who did not receive rescue medication, the time of censoring was cut off at 24 hours or the time of withdrawal, whichever was earlier. Kaplan-Meier method was used for estimation.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=2 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=2 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=2 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=2 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Time to First Use of Rescue Therapy or Medication
|
14.9 Hours
Interval 1.6 to
Upper limit of 95% CI could not be estimated due to low number of participants.
|
2.3 Hours
Interval 1.8 to
Upper limit of 95% CI could not be estimated due to low number of participants.
|
15.3 Hours
Interval 1.6 to
Upper limit of 95% CI could not be estimated due to low number of participants.
|
10.3 Hours
Interval 1.5 to
Upper limit of 95% CI could not be estimated due to low number of participants.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 2, 4, 6, and 24 hours post-dosePopulation: Pharmacokinetic (PK) parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771
|
652100 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
657500 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.5, 2, 4, 6, and 24 hours post dosePopulation: PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771
|
652400 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
658000 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.5, 2, 4, 6, and 24 hours post dosePopulation: PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-05089771
|
66760 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
59080 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.5, 2, 4, 6, and 24 hours post dosePopulation: PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771
|
3.95 Hours
Interval 2.0 to 6.07
|
6.00 Hours
Interval 4.0 to 6.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of Day 83Population: Safety analysis set included all participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of Day 73Population: Safety analysis set included all participants who received at least 1 dose of study medication.
Laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell count: less than(\<)0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell: \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil (absolute, %):\<0.8\*LLN/\>1.2\*ULN, total neutrophil \<0.8\*LLN;basophil, eosinophil, monocyte (absolute, %):\>1.2\*ULN; mean corpuscular (MC) volume, mean cell hemoglobin, MC hemoglobin concentration, mean platelet volume: \<0.9\*LLN/\>1.1\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN, uric acid \>1.2\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN/\>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketone, protein, blood/Hgb, urobilinogen, bilirubin, nitrite, leukocyte esterase \>=1).
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of Day 83Population: Safety analysis set included all participants who received at least 1 dose of study medication.
The minimum starting temperature to measure core body temperature used was 33 degree Celsius. Clinically significant changes from baseline in core body temperature was judged by investigator.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of Day 83Population: Safety analysis set included all participants who received at least 1 dose of study medication.
Criteria for clinically significant blood pressure abnormalities: systolic blood pressure \>=30 millimetre of Mercury (mmHg) change from baseline in same posture, systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline in same posture, diastolic blood pressure \<50 mmHg.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to a maximum of Day 83Population: Safety analysis set included all participants who received at least 1 dose of study medication.
Criteria for clinically significant abnormalities in ECG : PR interval \>=300 millisecond (msec) and 25 percent (%) increase when baseline \>200 msec, 50% increase when baseline less than or equal to (\<=) 200 msec; QRS interval \>=140 msec, \>=50% increase from baseline; QT interval \>=500 msec; QT interval corrected using the Fridericia formula (QTcF) 450 msec to \<480 msec, \>=480 msec, 30 to \<60 msec increase from baseline, \>=60 msec increase from baseline.
Outcome measures
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 Participants
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 Participants
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Session 1: PF-05089771 1600 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Session 1: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Session 2: PF-05089771 1600 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Session 2: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Session 1: PF-05089771 1600 mg
n=5 participants at risk
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1.
|
Treatment Session 1: Placebo
n=5 participants at risk
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1.
|
Treatment Session 2: PF-05089771 1600 mg
n=5 participants at risk
Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2.
|
Treatment Session 2: Placebo
n=5 participants at risk
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2.
|
|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Nervous system disorders
Headache
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Nervous system disorders
Hyperaesthesia
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Gastrointestinal disorders
Chapped lips
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
80.0%
4/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
60.0%
3/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
General disorders
Fatigue
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
General disorders
Feeling cold
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
General disorders
Feeling hot
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Investigations
Hepatic enzyme increased
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Nervous system disorders
Paraesthesia
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
60.0%
3/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
|
Vascular disorders
Flushing
|
80.0%
4/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER