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A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

NCT ID: NCT01472848

Last Updated: 2011-11-17

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.

Cohort 2

Group Type EXPERIMENTAL

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.

Cohort 3

Group Type EXPERIMENTAL

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Cohort 4

Group Type EXPERIMENTAL

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Cohort 5

Group Type EXPERIMENTAL

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Cohort 6

Group Type ACTIVE_COMPARATOR

PF 05212389 or placebo

Intervention Type DRUG

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Interventions

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PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.

Intervention Type DRUG

PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.

Intervention Type DRUG

PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Intervention Type DRUG

PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Intervention Type DRUG

PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Intervention Type DRUG

PF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Obesity

Exclusion Criteria

Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2201010&StudyName=A%20Study%20Of%20Gastrointestinal%20Tolerability%20Of%20PF05212389%20In%20Obese%20Subjects

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Other Identifiers

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B2201010

Identifier Type: -

Identifier Source: org_study_id