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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 May 9, 2018

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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A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
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
The 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).
The 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Type 2 Diabetes Mellitus
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01044537
B1621001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

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

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