First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
2018年2月22日 更新者：Pfizer
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo Controlled First-in-human Trial To Evaluate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06751979 After Oral Administration Of Single And Multiple Ascending Doses To Healthy Adult And Elderly Subjects
The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
55
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Glendale、California、アメリカ、91206
- Glendale Adventist Medical Center
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Glendale、California、アメリカ、91206
- California Clinical Trials Medical Group, Inc
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years or between the ages of 60 and 85 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs) at Screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
- Any severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Single Ascending Dose Cross-over
Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo).
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PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979).
The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.
Matched Placebo solution/suspension administered as single dose.
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実験的：Multiple Ascending Dose PF-06751979
Multiple dose administration to Healthy Subjects in parallel cohorts(PF-06751979)
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PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts.
The dose levels are 5 mg, 15 mg, 50 mg.
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プラセボコンパレーター：Multiple Ascending Dose Placebo
Multiple dose administration to Healthy Subjects in parallel cohorts(Placebo)
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Matched Placebo (solution/suspension)administered daily for 14 consecutive days.
PF-06751979 (solution/suspension) administered daily for 14 consecutive days.
The dose level is 50 mg.
Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
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実験的：Multiple Dose Elderly PF-06751979
Multiple dose administration to Healthy Elderly Subjects (PF-06751979)
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PF-06751979 (solution/suspension) administered daily for 14 consecutive days.
The dose level is 50 mg.
Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
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プラセボコンパレーター：Multiple Dose Elderly Placebo
Multiple dose administration to Healthy Elderly Subjects (Placebo)
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Matched Placebo (solution/suspension)administered daily for 14 consecutive days.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Part A: Baseline up to 47 days; Part B and C: Baseline up to 29 days
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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.
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Part A: Baseline up to 47 days; Part B and C: Baseline up to 29 days
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Number of Participants With Abnormal Physical Examinations Findings
時間枠：Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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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.
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Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Number of Participants With Abnormal Neurological Examinations Findings
時間枠：Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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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.
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Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline
時間枠：Baseline
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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.
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Baseline
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Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7
時間枠：Day 7
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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.
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Day 7
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Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14
時間枠：Day 14
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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.
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Day 14
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Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 19
時間枠：Day 19
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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.
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Day 19
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
時間枠：Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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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.
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Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Number of Participants With Laboratory Abnormalities
時間枠：Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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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)
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Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
時間枠：Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Following parameters were analyzed for examination of vital signs: supine systolic and diastolic blood pressure, pulse rate and body temperature.
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Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days
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Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
時間枠：Day 1
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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.
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Day 1
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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AUClast is the area under the plasma concentration time-curve from time zero to the time of last quantifiable concentration.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(dn) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Dn) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)(Dn) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Plasma Decay Half-Life (t1/2) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Apparent Oral Clearance (CL/F) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Drug clearance is the quantitative measure of the rate at which a drug substance is removed from the blood.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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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.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1
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Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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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.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
時間枠：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
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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
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Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
時間枠：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
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Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.
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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
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Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
時間枠：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
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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
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Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979
時間枠：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
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Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.
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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
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Part B: Apparent Oral Clearance (CL/F) of PF-06751979
時間枠：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
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Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood.
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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
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Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
時間枠：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
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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
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Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979
時間枠：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
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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.
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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
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Part B: Peak-to-Trough Ratio (PTR) of PF-06751979
時間枠：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
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PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant.
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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
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Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 7, 14
時間枠：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
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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.
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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
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Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979 at Day 7, 14
時間枠：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
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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.
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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
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Part B: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
時間枠：0-24 hours on Day 14
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Aetau is the amount of drug excreted unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours.
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0-24 hours on Day 14
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Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
時間枠：0-24 hours on Day 14
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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.
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0-24 hours on Day 14
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Part B: Renal Clearance of PF-06751979
時間枠：0-24 hours on Day 14
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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.
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0-24 hours on Day 14
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Part B: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) Fragments on Day 14
時間枠：Baseline, Day 14
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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.
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Baseline, Day 14
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Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
時間枠：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
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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
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Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
時間枠：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
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Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.
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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
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Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
時間枠：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
|
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
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Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979
時間枠：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
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Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.
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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
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Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979
時間枠：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
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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.
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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
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Part C: Apparent Oral Clearance (CL/F) of PF-06751979 on Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 on Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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Part C: Peak-to-Trough Ratio (PTR) of PF-06751979 at Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
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Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 14
時間枠：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
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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.
|
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
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Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF 06751979 at Day 14
時間枠：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
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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.
|
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
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Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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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.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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Part C: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14
時間枠：predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.
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predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年7月1日
一次修了 (実際)
2016年7月1日
研究の完了 (実際)
2016年7月1日
試験登録日
最初に提出
2015年7月22日
QC基準を満たした最初の提出物
2015年7月23日
最初の投稿 (見積もり)
2015年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月1日
QC基準を満たした最後の更新が送信されました
2018年2月22日
最終確認日
2018年2月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- B8271001
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