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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:10/18/2018
Start Date:September 15, 2014
End Date:January 27, 2017

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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

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


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
We found this trial at
9
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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DeLand, FL
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Chula Vista, California 91911
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High Point, North Carolina 27265
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South Miami, Florida 33143
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South Miami, FL
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South Miami, Florida 33143
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South Miami, FL
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