A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
23 september 2014 bijgewerkt door: Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Verwacht)
86
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06511
- Pfizer Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 64 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.
Exclusion Criteria:
- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: 2
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 1
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 4
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 3
|
Placebo for PF-06252616, IV infusion, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, IV infusion, repeat dose
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 6
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 7
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
Placebo-vergelijker: 5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Incidence of treatment related Adverse Events.
Tijdsspanne: Day 197
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Day 197
|
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Severity of treatment related Adverse Events.
Tijdsspanne: Day 197
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Day 197
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Incidence of abnormal lab findings.
Tijdsspanne: Day 197
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Day 197
|
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Magnitude of abnormal lab findings.
Tijdsspanne: Day 197
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Day 197
|
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Abnormal and clinically relevant changes in Blood Pressure.
Tijdsspanne: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in Pulse Rate.
Tijdsspanne: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in Respiratory Rate.
Tijdsspanne: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in temperature.
Tijdsspanne: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in ECG parameters.
Tijdsspanne: Day 197
|
Day 197
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
|
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Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
Tijdsspanne: Through Day 113 post dosing
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Through Day 113 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
Tijdsspanne: Through Day 197 post dosing
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Through Day 197 post dosing
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PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
Tijdsspanne: Through Day 197 post dosing
|
Through Day 197 post dosing
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2012
Primaire voltooiing (Werkelijk)
1 augustus 2014
Studie voltooiing (Werkelijk)
1 augustus 2014
Studieregistratiedata
Eerst ingediend
25 mei 2012
Eerst ingediend dat voldeed aan de QC-criteria
7 juni 2012
Eerst geplaatst (Schatting)
11 juni 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
25 september 2014
Laatste update ingediend die voldeed aan QC-criteria
23 september 2014
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- B5161001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .