| 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 without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to the follow up visit (up to 36 days in Part A, 49 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG003 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG004 | Part A: PF-06751979 200 mg Fed | All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG005 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG006 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG007 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG008 | Part C: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG009 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| | | Title | Denominators | Categories |
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| AEs | | |
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| Primary | Number of Participants With Abnormal Physical Examinations Findings | Full physical examination included head, ears, eyes, nose, mouth, skin, heart, lung, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Abnormality in physical examinations was based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Primary | Number of Participants With Abnormal Neurological Examinations Findings | The neurological examination included the assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait. Abnormality in neurological examinations was based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Primary | Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline | C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("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 self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at baseline were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 125 mg | |
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| Primary | Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 7 | C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("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 self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 7 were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol. | Posted | | Number | | participants | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 125 mg | |
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| Primary | Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14 | C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("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 self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 14 were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol. | Posted | | Number | | participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 125 mg | |
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| Primary | Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 19 | C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("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 self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 19 were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol. | Posted | | Number | | participants | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 125 mg | |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Criteria for abnormal values of ECG parameters: maximum pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); maximum PR interval increase from baseline (IFB): >=25 percent (%) when baseline was greater than (>)200 msec; or >=50 % when baseline was greater than (>)200 msec, maximum QRS interval >=140 msec and QRS interval IFB: >=50%. QT interval using Fridericia's correction (QTcF) ranges from 450 msec to maximum less than (<)480 msec, less than or equal to (<=) 480 msec to maximum <500 msec and maximum >=500 msec, maximum QTcF interval IFB range from <=30 to <60 msec and maximum >=60 msec. Only categories which included at least 1 participant with abnormality are reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Primary | Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry | In all Periods of Part A, continuous cardiac monitoring was maintained for 8 hours (or longer if considered clinically necessary by the investigator) following dose administration on Day 1. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern. | Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol. | Posted | | Number | | participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 400 mg | |
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| Primary | Number of Participants With Vital Sign Abnormalities | Criteria for vital signs abnormalities: systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), diastolic blood pressure (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum IFB in Supine SBP >=30 mmHg, Maximum decrease from baseline (DFB) in Supine SBP >=30 mmHg, maximum DFB in Supine DBP >=20 mmHg. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Primary | Number of Participants With Laboratory Abnormalities | Abnormalities criteria:hematology(hemoglobin; hematocrit; RBC<0.8*lower limit of normal [LLN]; platelets<0.5*LLN,>1.75*upper limit of normal [ULN]; WBC<0.6*LLN,>1.5*ULN; lymphocytes; neutrophils; basophils; eosinophils; monocytes<0.8*LLN,>1.2*ULN; coagulation(prothrombin ratio>1.1*ULN), liver(bilirubin>1.5*ULN; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma GT>0.3*ULN; protein; albumin<0.8*LLN,>1.2*ULN); renal(blood urea nitrogen, creatinine>1.3*ULN; uric acid>1.2*ULN); electrolytes(sodium<0.95*LLN,>1.05*ULN; potassium; chloride; calcium; bicarbonate<0.9*LLN,>1.1*ULN), chemistry(glucose<0.6*LLN,>1.5* ULN); urinalysis(pH <4.5,>8; glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte, esterase>1; WBC; bacteria>=20, epithelial cells>=6; granular casts, hyaline casts, red cell casts, white cell casts>1; lipids(cholesterol[C], LDL-C>1.3*ULN; HDL-C<0.8*LLN, triglycerides>1.3*ULN); hormones(T4, T3, T4, TSH<0.8*LLN,>1.2*ULN). | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 |
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| Secondary | Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | Pharmacokinetic (PK) parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Secondary | Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979 | Area under the plasma concentration-time profile from time zero to the time of last measured concentration (AUClast). | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | |
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| Secondary | Part A: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg |
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| Secondary | Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979 | Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in milligram) administered to a participant. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram per milliliter) per milligram | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Secondary | Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06751979 | AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered to a participant. AUClast was area under the plasma concentration-time profile from time zero to the time of last measured concentration. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram*hour/milliliter) per milligram | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | |
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| Secondary | Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf [dn]) of PF-06751979 | AUCinf (dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered to a participant. AUCinf was area under the plasma concentration-time profile from time zero extrapolated to infinite time (0-inf). | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram*hour/milliliter) per milligram | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | |
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| Secondary | Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Median | Full Range | hours | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | |
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| Secondary | Part A: Plasma Decay Half-Life (t1/2) of PF-06751979 | Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Mean | Standard Deviation | hours | | pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Secondary | Part A: Apparent Clearance (CL/F) of PF-06751979 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. |
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| Secondary | Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 200 mg | All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 400 mg | All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 540 mg | |
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| Secondary | Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points for each arm. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979 | Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm. | Posted | | Median | Full Range | hours | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979 | Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram per milliliter) per milligram | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979 | Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant. | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram*hour/milliliter)/milligram | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
|
| Secondary | Part B: Apparent Clearance (CL/F) of PF-06751979 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 | | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Peak-to-Trough Ratio of PF-06751979 | Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval. | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
| |
| Secondary | Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 | Rac for AUCtau for Day 7 was calculated as: AUCtau on Day 7 divided by AUCtau on Day 1. Rac for AUCtau for Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1. | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979 | Rac for Cmax on Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1 and Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration. | Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
|
| Secondary | Part B: Plasma Decay Half-Life (t1/2) of PF-06751979 | Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hour | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979 | Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Median | Full Range | hours | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979 | Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram per milliliter) per milligram | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979 | Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (nanogram*hour/milliliter)/milligram | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 | Minimum observed concentration during the dosing interval. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Peak-to-Trough Ratio of PF-06751979 | Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 | Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979 | Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Plasma Decay Half-Life (t1/2) of PF-06751979 | Plasma decay half-life was the time duration for the plasma concentration to decrease by one-half of its original concentration. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Mean | Standard Deviation | hours | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau) | Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours. | PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milligram | | 0-24 hours on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%) | Aetau% was calculated as: 100*Aetau/dose. Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours. | PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose excreated | | 0-24 hours on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Renal Clearance of PF-06751979 | Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated in urine. It was calculated as amount of drug excreted unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. | PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | 0-24 hours on Day 14 | | | | ID | Title | Description |
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| OG000 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 275 mg | Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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| Secondary | Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments | ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta 1-38, ABeta 1-40, ABeta 1-42, ABeta total, ABeta x-38, ABeta x-40, ABeta x-42, soluble amyloid precursor protein alpha (sAPP-alpha), soluble amyloid precursor protein beta (sAPP-beta) at Day 14 was reported in this outcome measure. | Pharmacodynamic CSF concentration population: all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. Number of participants analyzed= participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol. | Posted | | Mean | Standard Error | percent change | | Baseline, Day 14 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. | | OG001 | Part B: PF-06751979 125 mg | Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. |
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