Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

This study has been terminated.
(The study was terminated on December 19th, 2013 due to a business decision by the Sponsor. No safety concerns have been observed in this study.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01923389
First received: July 30, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Other: Placebo
Drug: 100 mg PF-05231023
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Day -7 through the last follow-up (Day 68) ] [ Designated as safety issue: Yes ]
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.

  • Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern [ Time Frame: Days -7 up to the last follow-up (Day 68) ] [ Designated as safety issue: Yes ]
    Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.

  • Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern [ Time Frame: Days -7 up to the last follow-up (Day 68) ] [ Designated as safety issue: Yes ]
    ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.

  • Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies. [ Time Frame: Days 1 up to the last follow-up (Day 68) ] [ Designated as safety issue: Yes ]
    Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.


Secondary Outcome Measures:
  • Number of Participants With Abnormal Clinical Laboratory Measurements [ Time Frame: Days -7 up to the last follow-up (Day 68) ] [ Designated as safety issue: Yes ]
    The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.

  • Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Days 1 and 25 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Days 1 and 25 ] [ Designated as safety issue: No ]
  • Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]
  • Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]
  • Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]
  • Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]
  • Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]
  • Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) [ Time Frame: Day 25 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.
Experimental: 100 mg PF-05231023 Drug: 100 mg PF-05231023
100 mg IV infusion twice a week for 4 weeks

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects of non-childbearing potential between the ages of 21 and 70.
  • Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

Exclusion Criteria:

  • Recent (6 months) unstable concurrent disease.
  • History of allergic disease or drug allergies.
  • Any condition affecting food consumption or absorption.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923389

Locations
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32804
Pfizer Investigational Site
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01923389     History of Changes
Other Study ID Numbers: B2901009
Study First Received: July 30, 2013
Results First Received: September 8, 2014
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
T2DM
obesity
safety
multiple dose
intravenous

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014