| 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 up to the follow up visit (up to 47 days in Part A, 29 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 47 days; Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG003 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG004 | Part A: PF-06751979 160 mg | Participants received 160 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG005 | Part B: Placebo | Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG006 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG007 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG008 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG009 | Part C: Placebo | Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG010 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| | | Title | Denominators | Categories |
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| AEs | | |
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| Primary | Number of Participants With Abnormal Physical Examinations Findings | A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, 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 47 days, Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 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 47 days, Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Primary | Part B and C: Number of Participants With Positive Response on 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 placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Primary | Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on 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, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any 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 placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Primary | Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on 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, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any 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 placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Primary | Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on 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, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any 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 placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Primary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for clinically significant ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30 change <60 or >=60 msec from baseline. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg |
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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 (PT); PT 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 47 days, Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg |
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| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Following parameters were analyzed for examination of vital signs: supine systolic and diastolic blood pressure, pulse rate and body temperature. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 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 | Continuous cardiac telemetry was conducted in participants. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern. In this outcome measure, number of participants who had cardiac rhythms of potential clinical concern (based on physician's discretion) 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 B and C, as pre specified in protocol. | Posted | | Number | | participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants received placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Secondary | Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | The pharmacokinetic (PK) parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG003 |
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| Secondary | Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979 | AUClast is the area under the plasma concentration time-curve from time zero to the time of last quantifiable concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Secondary | Part A: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979 | | PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'number of participants analyzed'= participants evaluable for this outcome measure. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Secondary | Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(dn) of PF-06751979 | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [nanogram/milliliter]/milligram | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 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. | PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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]/milligram | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 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 0 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. | PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'number of participants analyzed'= participants evaluable for this outcome measure. 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]/milligram | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg |
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| Secondary | Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Median | Full Range | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG003 | Part A: PF-06751979 160 mg |
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| Secondary | Part A: Plasma Decay Half-Life (t1/2) of PF-06751979 | Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Secondary | Part A: Apparent Oral Clearance (CL/F) of PF-06751979 | Drug clearance is the quantitative measure of the rate at which a drug substance is removed from the blood. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 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 plasma concentration of a drug. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part A: PF-06751979 3 mg | Participants received 3 mg oral solution of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG001 | Part A: PF-06751979 12 mg | Participants received 12 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. | | OG002 | Part A: PF-06751979 40 mg | Participants received 40 mg oral suspension of PF-06751979 in either 1 of the 4 intervention periods in Part A. A washout period of at least 7 days was maintained between each intervention period. |
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| Secondary | Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14 | 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 plasma concentration of a drug. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| 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 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | |
|
| Secondary | Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Median | Full Range | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979 | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [nanogram/milliliter]/milligram | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Apparent Oral Clearance (CL/F) of PF-06751979 | Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979 | Dose normalized area under the concentration curve from time 0 to end of dosing interval (AUCtau)(dn), 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. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | |
|
| Secondary | Part B: Peak-to-Trough Ratio (PTR) of PF-06751979 | PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 7, 14 | 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. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | |
|
| Secondary | Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979 at Day 7, 14 | Rac for Cmax for Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1. Rac for Cmax for Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 |
|
| Secondary | Part B: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14 | Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Mean | Standard Deviation | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau) | Aetau is the amount of drug excreted unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. 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 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| 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 is the amount of drug excreted unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. 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 excreted | | 0-24 hours on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Renal Clearance of PF-06751979 | Renal clearance 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. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. 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 |
|---|
| OG000 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part B: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) Fragments on Day 14 | ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta x-40, ABeta 1-40 and ABeta total) at Day 14 was reported in this outcome measure. | The pharmacodynamic CSF concentration population was defined as all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. 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 |
|---|
| OG000 | Part B: Placebo | Participants received placebo matched to PF-06751979 once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG001 | Part B- PF-06751979 5 mg | Participants received PF-06751979 5 mg oral solution once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. | | OG002 | Part B- PF-06751979 15 mg | Participants received PF-06751979 15 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
|
| Secondary | Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| 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 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours. | PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies participants who were evaluable at specified time points. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hour post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | | Median | Full Range | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979 | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [nanogram/milliliter]/milligram | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979 | Dose normalized area under the concentration curve from time 0 to end of dosing interval (AUCtau)(dn), 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 population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies participants who were evaluable at specified time points. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Apparent Oral Clearance (CL/F) of PF-06751979 on Day 14 | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 on Day 14 | | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,'number of participants analyzed'=participants evaluable for this outcome measure. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Peak-to-Trough Ratio (PTR) of PF-06751979 at Day 14 | PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,'number of participants analyzed'=participants evaluable for this outcome measure. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
| |
| Secondary | Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 14 | Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1, where Cmax was the maximum observed plasma concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,'number of participants analyzed'=participants evaluable for this outcome measure. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Secondary | Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF 06751979 at Day 14 | Rac for Cmax for Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,'number of participants analyzed'=participants evaluable for this outcome measure. 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 | | predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Secondary | Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14 | 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 plasma concentration of a drug. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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| Secondary | Part C: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14 | Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration. | The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, 'number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hours | | predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14 | | | | ID | Title | Description |
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| OG000 | Part C: PF-06751979 50 mg | Participants received PF-06751979 50 mg oral suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to Day 29. |
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