A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
Status and phase
Terminated
Phase 1
Conditions
Diabetes Mellitus, Type 2
Treatments
Drug: PF-05190457 or Placebo
Details and patient eligibility
About
The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
Enrollment
35 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
- 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
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- 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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
35 participants in 7 patient groups
2 mg PF-05190457 or Placebo BID
Experimental group
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
10 mg PF-05190457 or Placebo BID
Experimental group
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
40 mg PF-05190457 or Placebo BID
Experimental group
Description:
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
150 mg PF-05190457 or Placebo BID
Experimental group
Description:
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
5 mg PF-05190457 or Placebo QD
Experimental group
Description:
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
50 mg PF-05190457 or Placebo QD
Experimental group
Description:
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
xxx mg PF-05190457 or Placebo
Experimental group
Description:
Dose and dose frequency to be determined based on emerging safety and PK data.
Treatment:
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Drug: PF-05190457 or Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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