A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

NCT02211261

Last updated date
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women of non-childbearing potential with Type 2 Diabetes Mellitus

- Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening

- HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening

- Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of Type 1 diabetes mellitus


- Evidence of diabetic complications with significant end-organ damage


- History of chronic pancreatitis or at high risk for pancreatitis


- Poorly controlled hypertension


- History of cardiovascular or cerebrovascular event or procedure

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus
Brief Summary A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
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 Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Biological: PF-06293620
    subcutaneous, single dose 0.3 mg/kg
  • Biological: Placebo
    Subcutaneous normal saline single dose
  • Biological: PF-06293620
    Subcutaneous, single dose 1.0 mg/kg
  • Biological: PF-06293620
    Subcutaneous single dose 3 mg/kg
  • Biological: PF-06293620
    Subcutaneous single dose 6 mg/kg
  • Biological: PF-06293620
    Intravenous infusion single dose 1 mg/kg
  • Biological: Placebo
    Intravenous infusion normal saline single dose
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
  • Biological: Placebo
    Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose TBD mg (Days TBD)
  • Biological: Placebo
    Subcutaneous injection normal saline multiple dose (Days TBD)
Study Arms  ICMJE
  • Experimental: Cohort 1-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 2-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 3-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 4-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 5-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 6-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 7 PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 8-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 9-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: 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
Actual Enrollment  ICMJE
 (submitted: May 8, 2017)
84
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2014)
48
Actual Study Completion Date  ICMJE January 27, 2017
Actual Primary Completion Date January 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
  • Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
  • HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
  • Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria:

  • History of Type 1 diabetes mellitus
  • Evidence of diabetic complications with significant end-organ damage
  • History of chronic pancreatitis or at high risk for pancreatitis
  • Poorly controlled hypertension
  • History of cardiovascular or cerebrovascular event or procedure
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02211261
Other Study ID Numbers  ICMJE B3501001
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 CenterPfizer
PRS Account Pfizer
Verification Date October 2018

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