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: March 18, 2014
Last verified: March 2014

July 30, 2013
March 18, 2014
September 2013
December 2013   (final data collection date for primary outcome measure)
  • Incidence and severity of all causality Adverse Events and treatment-emergent Adverse Events, ECG parameters, SBP, DBP, Pulse Rate, Laboratory trends and incidence of abnormalities per Sponsor's safety reporting standards. [ Time Frame: 68 Days ] [ Designated as safety issue: No ]
  • Anti-PF-05231023 antibodies and neutralizing antibodies [ Time Frame: 68 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01923389 on ClinicalTrials.gov Archive Site
  • PK of PF-05231023 after multiple intravenous doses including Cmax and Cmin [ Time Frame: 68 Days ] [ Designated as safety issue: No ]
  • PK of sub-components of PF-05231023 including AUCtau, Cmax, Tmax after a single dose and accumulation ratio (AUC and Cmax), Cmin and Cav after the last dose [ Time Frame: 68 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus (T2DM)
  • Other: Placebo
    0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.
  • Drug: 100 mg PF-05231023
    100 mg IV infusion twice a week for 4 weeks
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: 100 mg PF-05231023
    Intervention: Drug: 100 mg PF-05231023
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01923389
B2901009
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP