Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: PF-05190457; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247896

B3301001

Details and patient eligibility

About

PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo