A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
NCT ID: NCT01372163
Last Updated: 2012-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
35 participants
INTERVENTIONAL
2011-07-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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2 mg PF-05190457 or Placebo BID
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
10 mg PF-05190457 or Placebo BID
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
40 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
150 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
5 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
50 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
xxx mg PF-05190457 or Placebo
Dose and dose frequency to be determined based on emerging safety and PK data.
PF-05190457 or Placebo
Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.
Interventions
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PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
PF-05190457 or Placebo
Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m\^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.
Exclusion Criteria
* Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B3301002
Identifier Type: -
Identifier Source: org_study_id
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