A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-05161704 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202266

B2911002

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)

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).
• Any condition possibly affecting drug absorption (e.g., gastrectomy).
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 8 patient groups

5 mg PF-05161704 or Placebo

Experimental group

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

15 mg PF-05161704 or Placebo

Experimental group

Description:

Planned dose: may be modified based on emerging PK and safety data.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

50 mg PF-05161704 or Placebo

Experimental group

Description:

Planned dose: may be modified based on emerging PK and safety data.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

150 mg PF-05161704 or Placebo

Experimental group

Description:

Planned dose: may be modified based on emerging PK and safety data.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

xx mg PF-05161704 or Placebo

Experimental group

Description:

Planned dose and dosing regimen will be determined based on emerging PK and safety data.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

xxx mg PF-05161704 or Placebo

Experimental group

Description:

Dose will be determined based on data from previous 5 arms.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

yy mg PF-05161704 or Placebo

Experimental group

Description:

Dose will be determined based on data from previous 6 arms

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

yyy mg PF-05161704 or Placebo

Experimental group

Description:

Dose will be determined based on data from previous 7 arms.

Treatment:

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo

Drug: PF-05161704 or Placebo