Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01285518
First received: January 26, 2011
Last updated: September 16, 2011
Last verified: September 2011
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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
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 June 18, 2013