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
Results First Received: September 8, 2014  
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
Condition: Type 2 Diabetes Mellitus (T2DM)
Interventions: Other: Placebo
Drug: 100 mg PF-05231023

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
PF-05231023 100 mg PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.

Participant Flow:   Overall Study
    Placebo     PF-05231023 100 mg  
STARTED     2     2  
COMPLETED     1     2  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication (PF-05231023 or placebo).

Reporting Groups
  Description
Placebo Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
PF-05231023 100 mg PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
Total Total of all reporting groups

Baseline Measures
    Placebo     PF-05231023 100 mg     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  39.0  ± 4.2     34.0  ± 5.7     36.5  ± 5.0  
Gender  
[units: Participants]
     
Female     1     0     1  
Male     1     2     3  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Day -7 through the last follow-up (Day 68) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Primary:   Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.   [ Time Frame: Days 1 up to the last follow-up (Day 68) ]

5.  Secondary:   Number of Participants With Abnormal Clinical Laboratory Measurements   [ Time Frame: Days -7 up to the last follow-up (Day 68) ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)   [ Time Frame: Day 25 ]

11.  Secondary:   Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)   [ Time Frame: Day 25 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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