A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
23. september 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Forventet)
86
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
- Pfizer Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 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 komparator: 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 komparator: 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 komparator: 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 komparator: 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 komparator: 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 komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of treatment related Adverse Events.
Tidsramme: Day 197
|
Day 197
|
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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
|
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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
|
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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
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. august 2014
Studiet fullført (Faktiske)
1. august 2014
Datoer for studieregistrering
Først innsendt
25. mai 2012
Først innsendt som oppfylte QC-kriteriene
7. juni 2012
Først lagt ut (Anslag)
11. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
25. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. september 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- B5161001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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