Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01673178
First received: August 22, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023


Condition Intervention Phase
Diabetes Mellitus, Type 2
Other: Placebo
Drug: 25 mg PF-05231023
Drug: 50 mg PF-05231023
Drug: 100 mg PF-05231023
Drug: 150 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: Treatment
Official Title: A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple IV Doses Of PF-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of multiple intravenous doses of PF-05231023 administered once weekly to obese adult subjects with hypertriglyceridemia with and without Type 2 diabetes mellitus (T2DM). [ Time Frame: 27 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics of PF-05231023 after multiple intravenous doses administered once weekly to obese adult subjects with hypertriglyceridemia with and without Type 2 diabetes mellitus (T2DM). [ Time Frame: 27 Days ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm Other: Placebo
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
Experimental: 25 mg Drug: 25 mg PF-05231023
25 mg IV once a week for 4 weeks
Experimental: 50 mg Drug: 50 mg PF-05231023
50 mg IV once a week for 4 weeks
Experimental: 100 mg Drug: 100 mg PF-05231023
100 mg IV once a week for 4 weeks
Experimental: 150 mg Drug: 150 mg PF-05231023
150 mg IV once a week for 4 weeks

  Eligibility

Ages Eligible for Study:   30 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 30 and 70 years with and without a diagnosis of Type 2 diabetes mellitus (according to the American Diabetes Association guidelines).
  • Subjects with poor lipid control as confirmed by laboratory tests.
  • BMI of 30 to 40 Kg/m2 and a total body weight of >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding asymptomatic, seasonal allergies at time of dosing).
  • Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes outside of the laboratory's reference range as confirmed by laboratory tests.
  • Subjects with Type 1 Diabetes Mellitus.
  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: NCT01673178

Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Chula Vista, California, United States, 91911
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
United States, North Carolina
Pfizer Investigational Site
High Point, North Carolina, United States, 27265
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45255
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75247
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: NCT01673178     History of Changes
Other Study ID Numbers: B2901011
Study First Received: August 22, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Type 2 diabetes
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