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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
PF-06293620
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring first in human, single dose, multiple dose, escalation, safety study, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Profil Institute for Clinical Research, Inc.
  • Profil Institute for Clinical Research, Incorporated
  • Avail Clinical Research, LLC
  • Orlando Clinical Research Center
  • Qps Mra, Llc
  • Qps-Mra Llc
  • High Point Clinical Trials Center, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1-PF-06293620 or placebo

Cohort 2-PF-06293620 or placebo

Cohort 3-PF-06293620 or placebo

Cohort 4-PF-06293620 or placebo

Cohort 5-PF-06293620 or placebo

Cohort 6-PF-06293620 or placebo

Cohort 7 PF-06293620 or placebo

Cohort 8-PF-06293620 or placebo

Cohort 9-PF-06293620 or placebo

Arm Description

Single Ascending Dose PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
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.
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Clearance (CL) of PF-06293620 (SAD Cohorts)
Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was 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.
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was 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.
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was 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.
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).

Full Information

First Posted
August 6, 2014
Last Updated
October 15, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02211261
Brief Title
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2014 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
January 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
first in human, single dose, multiple dose, escalation, safety study, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Single Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 2-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Single Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 3-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Single Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 4-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Single Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 5-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Single Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 6-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Multiple Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 7 PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Multiple Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 8-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Multiple Ascending Dose PF-06293620 or placebo
Arm Title
Cohort 9-PF-06293620 or placebo
Arm Type
Experimental
Arm Description
Multiple Ascending Dose PF-06293620 or placebo
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
subcutaneous, single dose 0.3 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous normal saline single dose
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous, single dose 1.0 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous normal saline single dose
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous single dose 3 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous normal saline single dose
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous single dose 6 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous normal saline single dose
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Intravenous infusion single dose 1 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intravenous infusion normal saline single dose
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
Intervention Type
Biological
Intervention Name(s)
PF-06293620
Intervention Description
Subcutaneous injection multiple dose TBD mg (Days TBD)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection normal saline multiple dose (Days TBD)
Primary Outcome Measure Information:
Title
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Description
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.
Title
Number of Participants With Dose Limiting or Intolerable Adverse Events
Description
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
Title
Number of Participants With Positive Anti-drug Antibody (ADA) Result
Description
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 Outcome Measure Information:
Title
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
Description
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.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
Description
AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Description
Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
Description
AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Clearance (CL) of PF-06293620 (SAD Cohorts)
Description
Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
Description
Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
Description
Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
Description
Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
Description
Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
Description
Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
Description
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was 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.
Time Frame
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Title
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Description
Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Description
Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Description
Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Description
Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Description
Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was 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.
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Description
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was 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.
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
Description
Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Title
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
Description
Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
Time Frame
Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute for Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Profil Institute for Clinical Research, Incorporated
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Qps Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Qps-Mra Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
High Point Clinical Trials Center, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3501001&StudyName=A%20Phase%201%20Single%20Dose%20Study%20Of%20PF-06293620%20To%20Assess%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20In%20Subjects%20With%20Type%202%20Diabetes%20Mell
Description
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Learn more about this trial

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

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