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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: Placebo; Biological: PF-06293620

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211261

B3501001

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 9 patient groups

Cohort 1-PF-06293620 or placebo

Experimental group

Description:

Single Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 2-PF-06293620 or placebo

Experimental group

Description:

Single Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 3-PF-06293620 or placebo

Experimental group

Description:

Single Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 4-PF-06293620 or placebo

Experimental group

Description:

Single Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 5-PF-06293620 or placebo

Experimental group

Description:

Single Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 6-PF-06293620 or placebo

Experimental group

Description:

Multiple Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 7 PF-06293620 or placebo

Experimental group

Description:

Multiple Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 8-PF-06293620 or placebo

Experimental group

Description:

Multiple Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Cohort 9-PF-06293620 or placebo

Experimental group

Description:

Multiple Ascending Dose PF-06293620 or placebo

Treatment:

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: Placebo

Biological: Placebo

Biological: PF-06293620

Biological: PF-06293620