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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01616277
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 25, 2012
First Posted Date  ICMJE June 11, 2012
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Incidence of treatment related Adverse Events. [ Time Frame: Day 197 ]
  • Severity of treatment related Adverse Events. [ Time Frame: Day 197 ]
  • Incidence of abnormal lab findings. [ Time Frame: Day 197 ]
  • Magnitude of abnormal lab findings. [ Time Frame: Day 197 ]
  • Abnormal and clinically relevant changes in Blood Pressure. [ Time Frame: Day 197 ]
  • Abnormal and clinically relevant changes in Pulse Rate. [ Time Frame: Day 197 ]
  • Abnormal and clinically relevant changes in Respiratory Rate. [ Time Frame: Day 197 ]
  • Abnormal and clinically relevant changes in temperature. [ Time Frame: Day 197 ]
  • Abnormal and clinically relevant changes in ECG parameters. [ Time Frame: Day 197 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01616277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration) [ Time Frame: Through Day 197 post dosing ]
  • Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay [ Time Frame: Through Day 197 post dosing ]
  • Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay [ Time Frame: Through Day 197 post dosing ]
  • Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA [ Time Frame: Through Day 113 post dosing ]
  • PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: 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) [ Time Frame: Through Day 197 post dosing ]
  • PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time) [ Time Frame: Through Day 197 post dosing ]
  • PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum) [ Time Frame: 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) [ Time Frame: 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.) [ Time Frame: 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. [ Time Frame: Through Day 197 post dosing ]
  • Steady state volume of distribution is the apparent volume of distribution at steady-state.) [ Time Frame: Through Day 197 post dosing ]
  • PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC) [ Time Frame: Through Day 197 post dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06252616
    1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Drug: Placebo
    Placebo for PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252161
    10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
  • Drug: Placebo
    Placebo for PF-06252616, Subcutaneous injection, single dose
  • Biological: PF-06252616
    10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
  • Drug: Placebo
    Placebo for PF-06252616, IV infusion, repeat dose
  • Biological: PF-06252616
    20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Study Arms  ICMJE
  • Placebo Comparator: 1
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 2
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 3
    Interventions:
    • Biological: PF-06252161
    • Drug: Placebo
  • Placebo Comparator: 4
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 5
    Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 6
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 7
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
63
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616277
Other Study ID Numbers  ICMJE B5161001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP