- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02184429
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
4. září 2018 aktualizováno: Pfizer
A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571.
Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571.
During multiple dose phase, PF-06669571 will be administered daily for 14 days
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
56
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Connecticut
-
New Haven, Connecticut, Spojené státy, 06511
- New Haven Clinical Research Unit
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
- For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Single Ascending Dose-1
Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Single Ascending Dose-2
Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Multiple Ascending Dose-1
Daily dose of PF-06669571 in healthy volunteers
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Multiple Ascending Dose-2
Daily dose of PF-06669571 in healthy volunteers
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Multiple Ascending Dose-3
Daily dose of PF-06669571 in healthy volunteers
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Multiple Ascending Dose-4
Daily dose of PF-06669571 in healthy volunteers
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
|
Experimentální: Multiple Ascending Dose-5
Daily dose of PF-06669571 in healthy volunteers
|
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days.
This dose may be reached by a titration scheme
Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days.
This dose may be reached by a titration scheme
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Časové okno: screening,Day 28
|
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
|
screening,Day 28
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) after single dose
Časové okno: 0-Day 5
|
Cmax after a single dose
|
0-Day 5
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose
Časové okno: 0-Day 5
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
|
0-Day 5
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose
Časové okno: 0-Day 5
|
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
|
0-Day 5
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose
Časové okno: 0-Day 5
|
Tmax after single dose
|
0-Day 5
|
|
Plasma Decay Half-Life (t1/2) after single dose
Časové okno: 0-Day 5
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
|
0-Day 5
|
|
Apparent Oral Clearance (CL/F) after single dose
Časové okno: 0-Day 5
|
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 after single dose
|
0-Day 5
|
|
Apparent Volume of Distribution (Vz/F) after single dose
Časové okno: 0-Day 5
|
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-Day 5
|
|
Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses
Časové okno: 0-Day 18
|
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-Day 18
|
|
Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses
Časové okno: 0-day 18
|
0-day 18
|
|
|
Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses
Časové okno: 0-Day 18
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
0-Day 18
|
|
Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses
Časové okno: 0-Day 18
|
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-Day 18
|
|
Renal clearance (CLr) on day 14
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses
Časové okno: 0-Day 18
|
0-Day 18
|
|
|
Peak to Trough ratio at Steady State (PTR)
Časové okno: 0-Day 18
|
Cmax to Cmin ratio at steady state
|
0-Day 18
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2014
Primární dokončení (Aktuální)
1. března 2015
Dokončení studie (Aktuální)
1. března 2015
Termíny zápisu do studia
První předloženo
3. července 2014
První předloženo, které splnilo kritéria kontroly kvality
3. července 2014
První zveřejněno (Odhad)
9. července 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
6. září 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. září 2018
Naposledy ověřeno
1. března 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B7821001
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Zdravý
-
University of ZurichDokončenoOutcome Assessment, Health CareŠvýcarsko
-
University of BernUniversity Hospital Inselspital, BerneDokončenoNeuroscience of Dreaming, HealthŠvýcarsko
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciDokončenoPreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
Queens College, The City University of New YorkNáborZveřejnění článků předložených American Journal of Public HealthSpojené státy
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciZatím nenabírámePreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
University of WashingtonNational Institute of Environmental Health Sciences (NIEHS)Aktivní, ne náborTeplo | Havarijní připravenost | Extrémní teplo | Health Health | Extrémní tepelné vlny | Řízení katastrof | Plánování katastrof | KatastrofySpojené státy
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsDokončenoBolest | Užívání opioidů | Totální náhrada kolena | Aplikace E-healthHolandsko
-
Universidad de ZaragozaNáborProfesionální integrace nově odstupňovaných pracovních terapeutů | Peer Mentorship in Health Professions | Přechod včasného kariéry a profesní identitaŠpanělsko
-
Gümüşhane UniversıtyKaradeniz Technical UniversityDokončenoRegistrováno u Kelkit District State Hospital Home Health Unit | Být pacientem domácí péčeKrocan
-
FIDMAG Germanes HospitalàriesUniversity of BarcelonaDokončenoPorucha duševního zdraví | Duševní zdraví wellness 1 | Role sestry | Care Acceptor, Health | Vztah, sestra pacientaŠpanělsko
Klinické studie na PF-06669571
-
PfizerDokončenoIdiopatická Parkinsonova nemocSpojené státy
-
PfizerDokončeno
-
PfizerDokončeno
-
University of FloridaDokončenoGastrointestinální příznaky | Frekvence stolice | Gastrointestinální tranzitní časSpojené státy
-
PfizerDokončeno
-
PfizerDokončeno
-
PfizerDokončenoNealkoholické ztučnění jater | Nealkoholická steatohepatitida s jaterní fibrózouHongkong, Spojené státy, Tchaj-wan, Portoriko, Čína, Kanada, Korejská republika, Bulharsko, Japonsko, Indie, Polsko, Slovensko
-
PfizerDokončeno
-
PfizerDokončenoDiabetes mellitus, typ 1Spojené státy