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
  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:
  • 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

  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
Last Updated: March 18, 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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014