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A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Dedicated Phase 1
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with type 2 diabetes mellitus who are taking stable doses of metformin only.
Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor
(DPP-IVi) in combination with metformin may be eligible if washed off the SU or
DPP-IVi to metformin only for a minimum of 4 weeks before dosing.

- Male and/or female subjects (females will be women of non childbearing potential)
between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5
to 45.0 kg/m2 and C-peptide >0.8 ng/mL.

- Screening and Day -2 troponin I concentration =0.05 ng/mL as measured by the Bayer
Centaur Ultra assay.

- HbA1c >/=7% and =11%. If the patient requires to be washed off an SU or DPP-IVi,
the HbA1c limits will be >/=7% and =9.5%.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Evidence or history of diabetic complications with significant end organ damage, eg,
proliferative retinopathy and/or macular edema, creatinine clearance =60 mL/min
based on the Cockcroft-Gault equation, diabetic neuropathy complicated by neuropathic
ulcers.

- History of stroke, transient ischemic attack, or myocardial infarction within the
past 6 months. Additionally, history of coronary artery bypass graft or stent
implantation, clinically significant peripheral vascular disease, or congestive heart
failure (NYHA Classes II-IV). Furthermore, a current history of angina/unstable
angina. Also, 12 lead electrocardiogram (ECG) demonstrating QTc >450 msec at
screening, ECG findings suggestive of asymptomatic myocardial ischemia, or supine
blood pressure >/=160 mm Hg (systolic) or =100 mm Hg (diastolic).

- One or more self reported episodes of hypoglycemia within the last 3 months, or two
or more self reported episodes of hypoglycemia within the last 6 months.

- Screening or Day -2 fasting (>/=8 hours) blood glucose, =70 or >/=270 mg/dL,
confirmed by a single repeat if deemed necessary.

NCT01044537
Pfizer
Completed
A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus

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Descriptive Information
Brief Title  ICMJE A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Oral Doses Of Pf-04937319 In Adult Subjects With Type 2 Diabetes Mellitus
Brief SummaryThe purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).
Detailed DescriptionThe purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Placebo
    Placebo to match PF-04937319 will be provided.
  • Drug: PF-04937319
    The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo.
    Intervention: Drug: Placebo
  • Experimental: PF-04937319
    In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. There will be approximately 6 dosing levels of PF-04937319
    Intervention: Drug: PF-04937319
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: June 7, 2010)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2010)
54
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion DateMay 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who are taking stable doses of metformin only. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor (DPP-IVi) in combination with metformin may be eligible if washed off the SU or DPP-IVi to metformin only for a minimum of 4 weeks before dosing.
  • Male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5 to 45.0 kg/m2 and C-peptide >0.8 ng/mL.
  • Screening and Day -2 troponin I concentration
  • HbA1c >/=7% and /=7% and

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance
  • History of stroke, transient ischemic attack, or myocardial infarction within the past 6 months. Additionally, history of coronary artery bypass graft or stent implantation, clinically significant peripheral vascular disease, or congestive heart failure (NYHA Classes II-IV). Furthermore, a current history of angina/unstable angina. Also, 12 lead electrocardiogram (ECG) demonstrating QTc >450 msec at screening, ECG findings suggestive of asymptomatic myocardial ischemia, or supine blood pressure >/=160 mm Hg (systolic) or
  • One or more self reported episodes of hypoglycemia within the last 3 months, or two or more self reported episodes of hypoglycemia within the last 6 months.
  • Screening or Day -2 fasting (>/=8 hours) blood glucose, /=270 mg/dL, confirmed by a single repeat if deemed necessary.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 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 NCT01044537
Other Study ID Numbers  ICMJE B1621001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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