Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Other: Placebo; Drug: 100 mg PF-05231023

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923389

B2901009

Details and patient eligibility

About

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.

Enrollment: 4 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects of non-childbearing potential between the ages of 21 and 70.
• Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

Exclusion criteria

• Recent (6 months) unstable concurrent disease.
• History of allergic disease or drug allergies.
• Any condition affecting food consumption or absorption.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

100 mg PF-05231023

Experimental group

Treatment:

Drug: 100 mg PF-05231023