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.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 30, 2013
Last updated: March 18, 2014
Last verified: March 2014

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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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


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

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
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Please refer to this study by its identifier: NCT01923389

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

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01923389     History of Changes
Other Study ID Numbers: B2901009
Study First Received: July 30, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
multiple dose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 21, 2014