Clinical trial NCT01285518: Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
Official title: A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of Pf-05231023 In Adult Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
intravenous
single dose
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* HbA1c \>7% and not to exceed 10.5%.

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).
* Diagnosis of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end organ damage.

Primary outcomes:
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Day -1 up to Day 22
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 22
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Day -1 up to Day 15
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Day 1 up to Day 15
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Screening up to Day 15
measure: Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels
timeFrame: Day 0 up to Day 22
measure: Number of Participants With Blood Glucose Abnormalities
timeFrame: Day -1 up to Day 15
measure: Number of Participants With Anti-Drug Antibodies (ADA): Day 1
timeFrame: Day 1
measure: Number of Participants With Anti-Drug Antibodies (ADA): Day 8
timeFrame: Day 8
measure: Number of Participants With Anti-Drug Antibodies (ADA): Day 15
timeFrame: Day 15
measure: Number of Participants With Anti-Drug Antibodies (ADA): Day 22
timeFrame: Day 22
measure: Number of Participants With Anti-Drug Antibodies (ADA): Day 34
timeFrame: Day 34
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1
timeFrame: Day 1
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2
timeFrame: Day 2
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3
timeFrame: Day 3
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5
timeFrame: Day 5
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7
timeFrame: Day 7
measure: Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15
timeFrame: Day 15
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1
timeFrame: Day 1
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2
timeFrame: Day 2
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3
timeFrame: Day 3
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5
timeFrame: Day 5
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7
timeFrame: Day 7
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15
timeFrame: Day 15
measure: Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry
timeFrame: From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Plasma Terminal Half-Life (t1/2) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing
timeFrame: Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Apparent Volume of Distribution (Vz) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
measure: Back-extrapolated Concentration at Time Zero (C0) of PF-05231023
timeFrame: 0.25 H post-dose to Bo on Day 1
measure: Volume of Distribution at Steady State (Vss) of PF-05231023
timeFrame: Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc.
state: California
city: Ft. Meyers
country: United States
facility: Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Miramar
country: United States
facility: Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
state: Florida
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: