Reflex Epilepsy, Photosensitive
Conditions
Brief summary
PF-06372865 in subjects with photosensitive epilepsy
Interventions
DRUGPlacebo
Placebo for PF-06372865 and placebo for lorazepam
DRUGPF-06372865
Single dose
DRUGLorazepam
2 mg single oral dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2 concomitant antiepileptic drugs. * Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks prior to Screening Visit. * A minimum average standardized photosensitive range (SPR) across all screening timepoints of 4 in the most sensitive eye condition and a non-zero average in at least one other eye condition.
Exclusion criteria
* Subjects with a history of status epilepticus. * Subjects who have experienced a generalized tonic-clonic convulsion in the past 6 months, at the time of the initial screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | Pre-dose, 1, 2, 4 and 6 hours post-dose | The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Pre-dose, 1, 2, 4 and 6 hours post-dose | Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions. |
| Maximum Plasma Concentration (Cmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | — |
| Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose | — |
| Time for Cmax (Tmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose | — |
| The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Pre-dose, 1, 2, 4 and 6 hours post-dose | The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose. |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | 17 weeks | Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. |
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 17 weeks | — |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 17 weeks | — |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | 19 weeks | The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in \>5% of subjects. AEs included serious AEs and non-serious AEs. |
| Plasma Concentration of Lorazepam | 1, 2, 3, 4 and 6 hours post-dose | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants A total of 7 participants were enrolled and assigned to study treatment. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 7.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 4 / 7 | 6 / 7 | 6 / 7 | 5 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.
Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose
Population: Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PF-06372865 17.5 mg | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 0.57 Units on a scale | Standard Error 0.98 |
| PF-06372865 52.5 mg | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 1.38 Units on a scale | Standard Error 0.96 |
| Lorazepam 2 mg | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 1.58 Units on a scale | Standard Error 0.97 |
| Placebo | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 6.80 Units on a scale | Standard Error 0.96 |
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-8.6, -3.86]Mixed Model Repeated Measures Analysis
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-7.78, -3.06]Mixed Model Repeated Measures Analysis
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-7.6, -2.84]Mixed Model Repeated Measures Analysis
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-1.58, 3.2]Mixed Model Repeated Measures Analysis
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-3.43, 1.41]Mixed Model Repreated Measure Analysis
Comparison: A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.90% CI: [-2.56, 2.16]Mixed Model Repeated Measures Analysis
Secondary
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Time frame: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Population: All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06372865 17.5 mg | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | 331.3 ng*hr/mL | Geometric Coefficient of Variation 22 |
| PF-06372865 52.5 mg | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | 771.4 ng*hr/mL | Geometric Coefficient of Variation 56 |
Secondary
Maximum Plasma Concentration (Cmax) of PF-06372865
Time frame: 1, 2, 4 and 6 hours post-dose
Population: All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06372865 17.5 mg | Maximum Plasma Concentration (Cmax) of PF-06372865 | 81.30 ng/mL | Geometric Coefficient of Variation 23 |
| PF-06372865 52.5 mg | Maximum Plasma Concentration (Cmax) of PF-06372865 | 200.6 ng/mL | Geometric Coefficient of Variation 45 |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Time frame: 17 weeks
Population: The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06372865 17.5 mg | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 0 Participants |
| PF-06372865 52.5 mg | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 0 Participants |
| Lorazepam 2 mg | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: 17 weeks
Population: The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06372865 17.5 mg | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 0 Participants |
| PF-06372865 52.5 mg | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 0 Participants |
| Lorazepam 2 mg | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Time frame: 17 weeks
Population: The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06372865 17.5 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 0 Participants |
| PF-06372865 52.5 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 0 Participants |
| Lorazepam 2 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (AEs)
The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in \>5% of subjects. AEs included serious AEs and non-serious AEs.
Time frame: 19 weeks
Population: The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06372865 17.5 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent non serious AEs | 4 Participants |
| PF-06372865 17.5 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent serious AEs | 0 Participants |
| PF-06372865 52.5 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent serious AEs | 0 Participants |
| PF-06372865 52.5 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent non serious AEs | 6 Participants |
| Lorazepam 2 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent non serious AEs | 6 Participants |
| Lorazepam 2 mg | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent serious AEs | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent non serious AEs | 5 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (AEs) | Treatment-emergent serious AEs | 0 Participants |
Secondary
Plasma Concentration of Lorazepam
Time frame: 1, 2, 3, 4 and 6 hours post-dose
Population: All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06372865 17.5 mg | Plasma Concentration of Lorazepam | 1 hours post dose | 7.38 ng/mL | Standard Deviation 5.92 |
| PF-06372865 17.5 mg | Plasma Concentration of Lorazepam | 2 hours post dose | 13.32 ng/mL | Standard Deviation 6.67 |
| PF-06372865 17.5 mg | Plasma Concentration of Lorazepam | 3 hours post dose | 17.10 ng/mL | Standard Deviation 4.32 |
| PF-06372865 17.5 mg | Plasma Concentration of Lorazepam | 4 hours post dose | 17.87 ng/mL | Standard Deviation 2.97 |
| PF-06372865 17.5 mg | Plasma Concentration of Lorazepam | 6 hours post dose | 15.93 ng/mL | Standard Deviation 1.92 |
Secondary
The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions.
Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose
Population: Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06372865 17.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Complete suppression | 85.7 Percentage of participants |
| PF-06372865 17.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | No response | 14.3 Percentage of participants |
| PF-06372865 17.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Partial response | 0 Percentage of participants |
| PF-06372865 52.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Complete suppression | 85.7 Percentage of participants |
| PF-06372865 52.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | No response | 14.3 Percentage of participants |
| PF-06372865 52.5 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Partial response | 0 Percentage of participants |
| Lorazepam 2 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Partial response | 0 Percentage of participants |
| Lorazepam 2 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Complete suppression | 85.7 Percentage of participants |
| Lorazepam 2 mg | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | No response | 14.3 Percentage of participants |
| Placebo | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Complete suppression | 28.6 Percentage of participants |
| Placebo | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | No response | 71.4 Percentage of participants |
| Placebo | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | Partial response | 0 Percentage of participants |
Secondary
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.
Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose
Population: Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06372865 17.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eye Closure | 0.57 Units on a scale | Standard Error 0.98 |
| PF-06372865 17.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Open | 0.04 Units on a scale | Standard Error 0.46 |
| PF-06372865 17.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Closed | 0.33 Units on a scale | Standard Error 0.57 |
| PF-06372865 52.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eye Closure | 1.38 Units on a scale | Standard Error 0.96 |
| PF-06372865 52.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Open | 0.09 Units on a scale | Standard Error 0.46 |
| PF-06372865 52.5 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Closed | 0.40 Units on a scale | Standard Error 0.57 |
| Lorazepam 2 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Closed | 1.09 Units on a scale | Standard Error 0.57 |
| Lorazepam 2 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eye Closure | 1.58 Units on a scale | Standard Error 0.97 |
| Lorazepam 2 mg | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Open | 0.08 Units on a scale | Standard Error 0.46 |
| Placebo | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eye Closure | 6.80 Units on a scale | Standard Error 0.96 |
| Placebo | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Open | 4.46 Units on a scale | Standard Error 0.51 |
| Placebo | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | Eyes Closed | 6.84 Units on a scale | Standard Error 0.64 |
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-8.6, -3.86]Mixed Model Repeated Measure Analysis
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-7.78, -3.06]Mixed Model Repeated Measures Analysis
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-7.6, -2.84]Mixed Model Repeated Measures Analysis
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-1.58, 3.2]Mixed Model Repeated Measures Analysis
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-3.43, 1.41]Mixed Model Repeated Measures Analysis
Comparison: In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-2.56, 2.16]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-8.01, -5.01]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-7.93, -4.95]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-7.2, -4.28]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-1.31, 1.46]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-2.19, 0.65]Mixed Model Repeated Measures Analysis
Comparison: In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-2.09, 0.7]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-5.6, -3.25]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-5.57, -3.17]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-5.57, -3.19]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-1.08, 1.19]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-1.18, 1.1]Mixed Model Repeated Measures Analysis
Comparison: In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.90% CI: [-1.11, 1.13]Mixed Model Repeated Measures Analysis
Secondary
Time for Cmax (Tmax) of PF-06372865
Time frame: 1, 2, 4 and 6 hours post-dose
Population: All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PF-06372865 17.5 mg | Time for Cmax (Tmax) of PF-06372865 | 2.12 hour | Full Range 22 |
| PF-06372865 52.5 mg | Time for Cmax (Tmax) of PF-06372865 | 3.02 hour | Full Range 56 |