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A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

NCT ID: NCT01202266

Last Updated: 2011-03-11

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5 mg PF-05161704 or Placebo

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

15 mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

50 mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

150 mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

xx mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast

xxx mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

yy mg PF-05161704 or Placebo

Dose will be determined based on data from previous 6 arms

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

yyy mg PF-05161704 or Placebo

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

Group Type EXPERIMENTAL

PF-05161704 or Placebo

Intervention Type DRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

Interventions

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PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

Intervention Type DRUG

PF-05161704 or Placebo

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

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

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2911002&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-05161704%20In%20Healthy%20Volunteers

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2911002

Identifier Type: -

Identifier Source: org_study_id

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