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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285518
• Other study ID #: B2901001
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2011
• Last updated: September 16, 2011
• Start date: February 2011
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• PF-05231023
0.5 mg QD IV x 1 day
• PF-05231023
1.5 mg QD IV x 1 day
• PF-05231023
5 mg QD IV x 1 day
• PF-05231023
15 mg QD IV x 1 day
• PF-05231023
50 mg QD IV x 1 day
• PF-05231023
100 mg QD IV x 1 day
• PF-05231023
200 mg QD IV x 1 day

Other:
• Placebo
0.9% w/v sodium chloride injection, USP QD IVx 1 day

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chula Vista	California
United States	Pfizer Investigational Site	Ft. Meyers	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miramar	Florida
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of escalating, single intravenous doses of PF-05231023 administered to adult subjects with Type 2 diabetes.		Up to 22 days post-single dose administration	Yes
Secondary	To characterize the pharmacokinetics of PF 05231023 after administration of escalating, single intravenous doses of PF 05231023 to adult subjects with Type 2 diabetes.		Up to Day 22 post-single dose administration	No

External Links

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