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A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

23. september 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

86

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 2
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 1
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 4
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 3
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252161
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 6
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 7
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo komparator: 5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
Biologisk: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Medicin: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biologisk: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Medicin: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biologisk: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biologisk: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of treatment related Adverse Events.
Tidsramme: Day 197
Day 197
Severity of treatment related Adverse Events.
Tidsramme: Day 197
Day 197
Incidence of abnormal lab findings.
Tidsramme: Day 197
Day 197
Magnitude of abnormal lab findings.
Tidsramme: Day 197
Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Tidsramme: Day 197
Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Tidsramme: Day 197
Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Tidsramme: Day 197
Day 197
Abnormal and clinically relevant changes in temperature.
Tidsramme: Day 197
Day 197
Abnormal and clinically relevant changes in ECG parameters.
Tidsramme: Day 197
Day 197

Sekundære resultatmål

Resultatmål
Tidsramme
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
Tidsramme: Through Day 113 post dosing
Through Day 113 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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).
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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.)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
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.
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
Tidsramme: Through Day 197 post dosing
Through Day 197 post dosing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

25. maj 2012

Først indsendt, der opfyldte QC-kriterier

7. juni 2012

Først opslået (Skøn)

11. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • B5161001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med PF-06252616

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Betingelser

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