Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01285518
First received: January 26, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-05231023
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of escalating, single intravenous doses of PF-05231023 administered to adult subjects with Type 2 diabetes. [ Time Frame: Up to 22 days post-single dose administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of PF 05231023 after administration of escalating, single intravenous doses of PF 05231023 to adult subjects with Type 2 diabetes. [ Time Frame: Up to Day 22 post-single dose administration ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: PF-05231023
0.5 mg QD IV x 1 day
Drug: PF-05231023
1.5 mg QD IV x 1 day
Drug: PF-05231023
5 mg QD IV x 1 day
Drug: PF-05231023
15 mg QD IV x 1 day
Drug: PF-05231023
50 mg QD IV x 1 day
Drug: PF-05231023
100 mg QD IV x 1 day
Drug: PF-05231023
200 mg QD IV x 1 day
Placebo Comparator: Placebo
0.9% w/v sodium chloride injection, USP
Other: Placebo
0.9% w/v sodium chloride injection, USP QD IVx 1 day

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
  • Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
  • HbA1c >7% and not to exceed 10.5%.

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 untreated, asymptomatic, seasonal allergies at time of dosing).
  • Diagnosis of Type 1 diabetes mellitus
  • Evidence of diabetic complications with significant end organ damage.
  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: NCT01285518

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
Ft. Meyers, Florida, United States, 33901
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Miramar, Florida, United States, 33025
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
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: NCT01285518     History of Changes
Other Study ID Numbers: B2901001
Study First Received: January 26, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Type 2 diabetes
intravenous
single dose

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 31, 2014