Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 22, 2012
November 6, 2013
October 2012
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01673178 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
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

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

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: Treatment
Diabetes Mellitus, Type 2
  • Other: Placebo
    0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
  • Drug: 25 mg PF-05231023
    25 mg IV once a week for 4 weeks
  • Drug: 50 mg PF-05231023
    50 mg IV once a week for 4 weeks
  • Drug: 100 mg PF-05231023
    100 mg IV once a week for 4 weeks
  • Drug: 150 mg PF-05231023
    150 mg IV once a week for 4 weeks
  • Placebo Comparator: Placebo Arm
    Intervention: Other: Placebo
  • Experimental: 25 mg
    Intervention: Drug: 25 mg PF-05231023
  • Experimental: 50 mg
    Intervention: Drug: 50 mg PF-05231023
  • Experimental: 100 mg
    Intervention: Drug: 100 mg PF-05231023
  • Experimental: 150 mg
    Intervention: Drug: 150 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.
 
Completed
107
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01673178
B2901011
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

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