Healthy
Conditions
Keywords
Single ascending doses, pharmacokinetics, safety, tolerability, healthy volunteers, cognitive impairment associated with schizophrenia (CIAS)
Brief summary
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
Detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Interventions
DRUGPF-04958242
Administered as specified in treatment arm
DRUGPlacebo
Administered as specified in treatment arm
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg Key
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Baseline up to Day 10 | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last study drug administration. | An AE was any untoward medical occurrence in a participant who received study drug. An 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | Baseline up to Day 10 | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\], mean corpuscular hemoglobin concentration \[MCHC\], platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (follicle stimulating hormone \[FSH\], and urine drug screening). |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Baseline up to Day 10 | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) \>=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mm Hg change from baseline in same posture or DBP \<50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline. |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | Baseline up to Day 10 | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (\>=)300 milliseconds (msec) or \>=25% increase when baseline is greater than (\>)200 msec and \>=50% increase when baseline is less than or equal to (=\<)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); and QTcF \>=450 msec or \>=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported. |
| Number of Participants With Abnormal Physical Examination Findings | Baseline up to Day 10 | A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. |
| Number of Participants With Abnormal Neurological Examination Findings | Baseline up to Day 10 | The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Normalized Cmax (Cmax[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Dose Normalized AUCinf (AUCinf[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Dose Normalized AUClast (AUClast[dn]) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Apparent Clearance (CL/F) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Apparent Volume of Distribution (Vz/F) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | — |
| Terminal Elimination Half-Life (t1/2) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
United States
Participant flow
Pre-assignment details
Twelve participants were assigned study treatment. All participants received the assigned PF-04958242 doses during 3 periods (6 participants each received 0.35 mg, 0.6 mg and 0.8 mg doses, respectively). Nine participants received placebo. Three participants did not complete the study and they were replaced during the conduct of the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Included all participants who received at least 1 dose of study treatment in any of the intervention periods | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Intervention Period | No longer willing to participate | 1 | 0 | 0 |
| First Intervention Period | Unable to comply with study dates | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 4 / 6 | 2 / 6 | 4 / 9 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 |
Outcome results
Primary
Number of Participants With Abnormal Neurological Examination Findings
The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA)
Time frame: Baseline up to Day 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Abnormal Neurological Examination Findings | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Abnormal Neurological Examination Findings | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Abnormal Neurological Examination Findings | 0 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination Findings | 0 participants |
Primary
Number of Participants With Abnormal Physical Examination Findings
A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Time frame: Baseline up to Day 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Abnormal Physical Examination Findings | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Abnormal Physical Examination Findings | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Abnormal Physical Examination Findings | 0 participants |
| Placebo | Number of Participants With Abnormal Physical Examination Findings | 0 participants |
Primary
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior).
Time frame: Baseline up to Day 10
Population: The safety analysis population included all participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicidal ideation | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicide attempt | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Self-injurious behavior, no suicidal intent | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Preparatory acts to imminent suicidal behavior | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Complete suicide | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Preparatory acts to imminent suicidal behavior | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicidal ideation | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Self-injurious behavior, no suicidal intent | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicide attempt | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Complete suicide | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Preparatory acts to imminent suicidal behavior | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Complete suicide | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicide attempt | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicidal ideation | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Self-injurious behavior, no suicidal intent | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicidal ideation | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Suicide attempt | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Complete suicide | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Preparatory acts to imminent suicidal behavior | 0 participants |
| Placebo | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline | Self-injurious behavior, no suicidal intent | 0 participants |
Primary
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\], mean corpuscular hemoglobin concentration \[MCHC\], platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (follicle stimulating hormone \[FSH\], and urine drug screening).
Time frame: Baseline up to Day 10
Population: The safety analysis population included all participants who received the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 1 participants |
| PF-04958242 0.6 mg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 2 participants |
| PF-04958242 0.8 mg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 1 participants |
| Placebo | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 3 participants |
Primary
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (\>=)300 milliseconds (msec) or \>=25% increase when baseline is greater than (\>)200 msec and \>=50% increase when baseline is less than or equal to (=\<)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); and QTcF \>=450 msec or \>=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Time frame: Baseline up to Day 10
Population: The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcB Interval >=500 msec | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Interval >=50% IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcB Interval >=500 msec | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Interval >=50% IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Interval >=50% IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcB Interval >=500 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Interval >=50% IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcB Interval >=500 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec IFB | 0 participants |
Primary
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) \>=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mm Hg change from baseline in same posture or DBP \<50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.
Time frame: Baseline up to Day 10
Population: The safety analysis population included all participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP <90 mm Hg | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP <50 mm Hg | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse >120 bpm | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate <40 bpm | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate >140 bpm | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg IFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg IFB | 1 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg DFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg DFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.35 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse >120 bpm | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg IFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 1 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate <40 bpm | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP <50 mm Hg | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP <90 mm Hg | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg DFB | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate >140 bpm | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg DFB | 1 participants |
| PF-04958242 0.6 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse >120 bpm | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg DFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate <40 bpm | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate >140 bpm | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg IFB | 1 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg DFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg IFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP <90 mm Hg | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg DFB | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| PF-04958242 0.8 mg | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP <50 mm Hg | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg DFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate >140 bpm | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg DFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing Pulse Rate <40 bpm | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg DFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP <90 mm Hg | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing SBP >=30 mm Hg IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse >120 bpm | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg DFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg IFB | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP <50 mm Hg | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Standing DBP >=20 mm Hg IFB | 1 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to 28 days after last study drug administration.
Population: The safety analysis population included all participants who received the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04958242 0.35 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-04958242 0.35 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04958242 0.6 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-04958242 0.8 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 participants |
| PF-04958242 0.8 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Secondary
Apparent Clearance (CL/F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Apparent Clearance (CL/F) | 128.6 milliliters per minute (mL/min) | Geometric Coefficient of Variation 40 |
| PF-04958242 0.6 mg | Apparent Clearance (CL/F) | 126.0 milliliters per minute (mL/min) | Geometric Coefficient of Variation 28 |
| PF-04958242 0.8 mg | Apparent Clearance (CL/F) | 146.9 milliliters per minute (mL/min) | Geometric Coefficient of Variation 26 |
Secondary
Apparent Volume of Distribution (Vz/F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Apparent Volume of Distribution (Vz/F) | 367.9 liters | Geometric Coefficient of Variation 45 |
| PF-04958242 0.6 mg | Apparent Volume of Distribution (Vz/F) | 327.0 liters | Geometric Coefficient of Variation 40 |
| PF-04958242 0.8 mg | Apparent Volume of Distribution (Vz/F) | 337.2 liters | Geometric Coefficient of Variation 43 |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 45.34 ng*h/mL | Geometric Coefficient of Variation 40 |
| PF-04958242 0.6 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 79.34 ng*h/mL | Geometric Coefficient of Variation 28 |
| PF-04958242 0.8 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 90.78 ng*h/mL | Geometric Coefficient of Variation 26 |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 42.79 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 36 |
| PF-04958242 0.6 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 76.00 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 22 |
| PF-04958242 0.8 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 88.27 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
Secondary
Dose Normalized AUCinf (AUCinf[dn])
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Dose Normalized AUCinf (AUCinf[dn]) | 129.7 ng*h/mL/mg | Geometric Coefficient of Variation 40 |
| PF-04958242 0.6 mg | Dose Normalized AUCinf (AUCinf[dn]) | 132.3 ng*h/mL/mg | Geometric Coefficient of Variation 28 |
| PF-04958242 0.8 mg | Dose Normalized AUCinf (AUCinf[dn]) | 113.6 ng*h/mL/mg | Geometric Coefficient of Variation 26 |
Secondary
Dose Normalized AUClast (AUClast[dn])
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Dose Normalized AUClast (AUClast[dn]) | 122.4 ng*h/mL/mg | Geometric Coefficient of Variation 37 |
| PF-04958242 0.6 mg | Dose Normalized AUClast (AUClast[dn]) | 126.6 ng*h/mL/mg | Geometric Coefficient of Variation 22 |
| PF-04958242 0.8 mg | Dose Normalized AUClast (AUClast[dn]) | 110.5 ng*h/mL/mg | Geometric Coefficient of Variation 24 |
Secondary
Dose Normalized Cmax (Cmax[dn])
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Dose Normalized Cmax (Cmax[dn]) | 8.923 mg/mL/mg | Geometric Coefficient of Variation 23 |
| PF-04958242 0.6 mg | Dose Normalized Cmax (Cmax[dn]) | 9.331 mg/mL/mg | Geometric Coefficient of Variation 29 |
| PF-04958242 0.8 mg | Dose Normalized Cmax (Cmax[dn]) | 7.745 mg/mL/mg | Geometric Coefficient of Variation 24 |
Secondary
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Maximum Observed Plasma Concentration (Cmax) | 3.119 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
| PF-04958242 0.6 mg | Maximum Observed Plasma Concentration (Cmax) | 5.602 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| PF-04958242 0.8 mg | Maximum Observed Plasma Concentration (Cmax) | 6.193 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 24 |
Secondary
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04958242 0.35 mg | Terminal Elimination Half-Life (t1/2) | 37.33 hours | Standard Deviation 27.17 |
| PF-04958242 0.6 mg | Terminal Elimination Half-Life (t1/2) | 34.10 hours | Standard Deviation 20.533 |
| PF-04958242 0.8 mg | Terminal Elimination Half-Life (t1/2) | 29.07 hours | Standard Deviation 14.691 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose
Population: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04958242 0.35 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 1.29 hours |
| PF-04958242 0.6 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 1.80 hours |
| PF-04958242 0.8 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 1.50 hours |