A Multiple Dose Study Of PF-06678552 In Healthy Subjects
29 июля 2014 г. обновлено: Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects
PF-06678552 is a new compound proposed for the treatment of hypercholesteremia.
The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
38
Фаза
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Brussels, Бельгия, B-1070
- Pfizer Investigational Site
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 55 лет (Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential.
- Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
- Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
|
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Экспериментальный: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Экспериментальный: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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|
Экспериментальный: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Экспериментальный: Cohort 5
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Экспериментальный: Cohort 6
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
Временное ограничение: 0 to 24 days post dose
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0 to 24 days post dose
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
|
|
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Amount of PF-06644927 excreted in urine (Ae) on day 14
Временное ограничение: 0-12 hours post dose
|
0-12 hours post dose
|
|
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Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
Временное ограничение: 0-12 hours post dose
|
0-12 hours post dose
|
|
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Renal clearance of PF-06644927 (CLr) on day 14
Временное ограничение: 0-12 hours post dose
|
0-12 hours post dose
|
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
|
|
|
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
|
Apparent Oral Clearance (CL/F) of PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
Apparent Oral Clearance (CL/F) of PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14
Временное ограничение: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
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.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 марта 2014 г.
Первичное завершение (Действительный)
1 июля 2014 г.
Завершение исследования (Действительный)
1 июля 2014 г.
Даты регистрации исследования
Первый отправленный
4 марта 2014 г.
Впервые представлено, что соответствует критериям контроля качества
4 марта 2014 г.
Первый опубликованный (Оценивать)
6 марта 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
31 июля 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 июля 2014 г.
Последняя проверка
1 июля 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- B7611002
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .