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

Pfizer84 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

PF-06293620BIOLOGICAL

subcutaneous, single dose 0.3 mg/kg

PlaceboBIOLOGICAL

Subcutaneous normal saline single dose

PF-06293620BIOLOGICAL

Subcutaneous, single dose 1.0 mg/kg

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (7)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Profil Institute for Clinical Research, Incorporated

Chula Vista, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.

Time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.

Number of Participants With Dose Limiting or Intolerable Adverse Events

Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.

Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Number of Participants With Positive Anti-drug Antibody (ADA) Result

ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.

Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Secondary Outcomes

Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)

Data from ClinicalTrials.gov

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Subcutaneous normal saline single dose

PF-06293620BIOLOGICAL

Subcutaneous single dose 3 mg/kg

PlaceboBIOLOGICAL

Subcutaneous normal saline single dose

PF-06293620BIOLOGICAL

Subcutaneous single dose 6 mg/kg

PlaceboBIOLOGICAL

Subcutaneous normal saline single dose

PF-06293620BIOLOGICAL

Intravenous infusion single dose 1 mg/kg

PlaceboBIOLOGICAL

Intravenous infusion normal saline single dose

PF-06293620BIOLOGICAL

Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)

PlaceboBIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

PF-06293620BIOLOGICAL

Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)

PlaceboBIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

PF-06293620BIOLOGICAL

Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)

PlaceboBIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

PF-06293620BIOLOGICAL

Subcutaneous injection multiple dose TBD mg (Days TBD)

PlaceboBIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days TBD)

Qps Mra, Llc

South Miami, Florida, United States

Qps-Mra Llc

South Miami, Florida, United States

High Point Clinical Trials Center, LLC

High Point, North Carolina, United States

AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.