A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
23 september 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Förväntat)
86
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06511
- Pfizer Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 64 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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-jämförare: 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-jämförare: 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-jämförare: 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-jämförare: 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-jämförare: 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-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Incidence of treatment related Adverse Events.
Tidsram: Day 197
|
Day 197
|
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Severity of treatment related Adverse Events.
Tidsram: Day 197
|
Day 197
|
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Incidence of abnormal lab findings.
Tidsram: Day 197
|
Day 197
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Magnitude of abnormal lab findings.
Tidsram: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in Blood Pressure.
Tidsram: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in Pulse Rate.
Tidsram: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in Respiratory Rate.
Tidsram: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in temperature.
Tidsram: Day 197
|
Day 197
|
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Abnormal and clinically relevant changes in ECG parameters.
Tidsram: Day 197
|
Day 197
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Tidsram: Through Day 197 post dosing
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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
Tidsram: Through Day 197 post dosing
|
Through Day 197 post dosing
|
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Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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 AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
Tidsram: 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).
Tidsram: 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 AUCτ (area under the curve serum concentration by dose interval)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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 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.)
Tidsram: 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.
Tidsram: 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.)
Tidsram: 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)
Tidsram: Through Day 197 post dosing
|
Through Day 197 post dosing
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 augusti 2014
Avslutad studie (Faktisk)
1 augusti 2014
Studieregistreringsdatum
Först inskickad
25 maj 2012
Först inskickad som uppfyllde QC-kriterierna
7 juni 2012
Första postat (Uppskatta)
11 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- B5161001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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